UK Gov bans e cig sales to under 18, so why did they support in Council an amended TPD that did not contain such an age restriction?

Today, the Government announced, via a press release  that they would be banning the sale of e-cigarettes to under 18 year olds.  This is welcome news.  Save E-cigs have been calling for this for months and responsible vendors have been doing this for years despite the lack of legislation.  E-cigarettes should not be sold to minors or non-smokers and we are delighted that the Government now agrees.

If however, this is the Government’s long held view, why did they support in Council an amended TPD that did not contain such an age restriction?

Despite welcoming the Government’s announcement, we seriously question the manner in which it was made.  Once again, the Government used this opportunity to peddle their standard misinformation regarding e-cigarettes.  We were told that this policy was being introduced to prevent children buying potentially “toxic” e-cigarettes.  That it was a response to “concerns that growing numbers of children are taking up e-cigarettes, before becoming addicted to nicotine and moving on to regular smoking.”  Most worrying of all, we were told that ministers had been moved to act following “anecdotal” evidence that e-cigarettes were gaining in popularity, with some reports of children smoking them in class.

Now we support this announcement, we called for such restrictions when the Government was not supportive, but legislation based on “anecdotal” evidence is very worrying.  Now let’s look at those government statements in a little more detail.

Research, including a recent survey commissioned by ASH[1], has shown time and time again that e-cigarettes are not attractive to young people, and are therefore not used as a gateway to smoking tobacco cigarettes.  Although awareness of e-cigarettes was widespread amongst young people aged 11 to 18, the ASH survey found no evidence that young people either used or perceived e-cigarettes as being a gateway to smoking.

Evidence produced by a variety of organisations including ASH and the American Cancer Society (ACS) clearly shows that flavours do not entice non-smokers to use e-cigarettes, especially the young, as they have no interest in the product.

Researchers from the ACS[2] looked specifically into the enticement of flavours.  They found that flavours did not increase the attractiveness of e-cigarettes to teenagers. Rather, “Even after controlling for other statistically significant correlates, the odds of a smoker being willing to try an e-cigarette were 10 times those of a non-smoker.”

Tobacco cigarettes are the gateway to tobacco smoking, not e-cigarettes.

As for the claim that e-cigarettes are potentially “toxic” and that we do not know what is in them, well again this is just not true.  We do know what is in them, PG, VG, nicotine, and flavourings.  Again many responsible manufacturers test their e liquid so they and we know exactly what is in them.  Only two weeks ago a group of vapers set up a crowd funding website to raise money to fund further independent testing.  We know that responsible manufacturers have also contributed.

These facts are readily available to anyone who cares to look, and Save E-cigs and countless others have been making policy makers aware of them for months.  Why then do the Government continue to peddle this misinformation and why do journalists publish them unquestioningly?  After all, the Government provide no evidence to support their claims; in fact they admit their evidence is “anecdotal”.

All this government misinformation and sloppy journalism does is scare people and encourage them to continue smoking tobacco cigarettes rather than switching to the safer e-cigarette.

So we welcome the fact that the Government has finally agreed to introduce age restrictions for the sale of e-cigarettes, but can government please, please, please stop making policy based on anecdotal evidence and instead start basing it on readily available independent factual evidence.  Is that really too much to ask?

 

[1] ASH surveyed 12,597 adults in 2010 – the questions focused on e-cigarette use and awareness in Great Britain. The preliminary survey was followed up by an additional study of adult smokers and non-smokers in February 2012 and more recently in 2013. ASH also surveyed children and young people aged 11 to 18 in March 2013.

Open letter to MEPs from the American trade association SAFTA

January 21, 2014

Dear MEP,

As the largest trade association dedicated to promoting education and information of personal electronic vapour (PEV) products such as electronic cigarettes, we at the Smoke-Free Alternatives Trade Association (SFATA) write to you today to express our concerns over Tobacco Products Directive and ask that you consider the facts and information we provide before rendering your decision.

SFATA represents seventy members, comprising a wide cross section of the “smoke-free” industry including distributors, manufacturers and retailers who will be hurt in different but equally damaging ways in the absence of appropriate and proportional regulation which meets the objectives of governments and public health regulators.

SFATA respectfully submits that changes made in trilogue to Article 18 render it an entirely new directive, deserving a fresh start and full review and point to the following issues in the current version of grave concern to our members:

A. Ban extension on refillable products

Depriving countless adult users of these products across the E.U. in the event that a block of any three member states eventually elects to ban them individually, would unfairly and disproportionally disenfranchise the voices, needs and contributions of businesses and consumers across the E.U. who deserve and support continued access to these technologies.

B. Consistent Dosing Requirement

Requiring that these products all deliver identical puffs would stifle the ongoing innovation that continues to drive superior and diverse products in the industry, which are designed to accommodate the customization and individuality desired by of adult consumers.

C. Limits on Nicotine Levels

Addiction to nicotine is both physical and behavioural; the proposed mandate requiring minimal amounts of nicotine ignores documented evidence that more than 20mg/ml of nicotine content is required for current smokers to successfully maintain the switch to vapour products like electronic cigarettes and is therefore inappropriate. See, Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Voudris V. “Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption: Implications for Research Protocol Standards Definition and for Public Health Authorities’ Regulation.” International Journal of Environmental Research and Public Health. 2013; 10(6):2500-2514. http://www.mdpi.com/1660-4601/10/6/2500

D. Bans on Advertising The proposed ban on advertising censors communications so as to prevent the industry from raising awareness about vaporizers and truthfully communicating with consumers about how vaporizers such as ecigs may serve as an alternative to tobacco products. We believe such censorship would create a severe disservice to adult consumers looking for accurate, truthful and helpful information about ecigs and how they may serve as an alternative to tobacco products.

E. Cross Border Sales Ban

Vaporizer technology products are neither medicinal nor pharmaceutical products and should not be treated as such. As you know, the EU Parliament recently voted against Amendment 71 of the TPD which would have seen ecigs legislated as medical products under restricted sale. The current proposed languages attempts to similarly and inappropriately misclassify vapour products like e-cigs as medicinal products and such language should not be adopted.

SFATA remains committed to ongoing communications and constructive engagement with the European Commission and Parliament so that appropriate regulations can be created which more acutely address the unique benefits, issues and concerns raised by vaporizing technologies.

SFATA believes that the concerns and issues raised can be directly addressed by the creation and implementation of Good Manufacturing Practices and Standards which are drafted in joint effort and collaboration between members of the industry and government.

Kind regards, Cynthia CabreraExecutive Director, SFATA

Joint Declaration of the E-cigarette Industry – the Regulation of E-cigarettes under the Tobacco Products Directive

Dear Chairman, Rapporteur and Shadow Rapporteurs
 
It has become apparent that the views of the European e-cigarette industry regarding the regulation of their products under the Tobacco Products Directive are being mis-represented to you and your fellow Members of ENVI.
 
Below and attached are joint declarations signed by a coalition of e-cigarette businesses in Continental Europe and the UK and 70 companies in the United States of America. As the regulation of e-cigarettes is currently being considered, developed and implemented in Brussels, London (and other capital cities across Europe) and Washington, our objective is to ensure a ‘collective’ industry voice to ensure an outcome – appropriate and proportional regulation and policy implementation – which meets the objectives of governments and public health regulators, is achievable for the growing industry and will realise the public health benefits offered by e-cigarette products as a safer alternative to cigarettes.
 
As you approach Wednesday’s ENVI meeting, please be aware of and note carefully the contents of these joint declarations.
 
 
 
Joint Declaration of the E-cigarette Industry – the Regulation of E-cigarettes under the Tobacco Products Directive
 
Changes made to Article 18 in trilogue arguably render it a new Directive and we note public health advocates of e-cigarettes and consumer groups are proposing that the European Commission should recommence the process and start a new consultation process on Article 18.
 
For the European e-cigarette industry, the specific problem issues within the current text are:
  1. Nicotine limits – as the key scientists in the field of tobacco and e-cigarettes have identified in their 16 January 2014 declaration (attached), a 20mg/ml nicotine content is proven as insufficient for smokers using e-cigarettes as a substitute for cigarettes
  2. Advertising ban – preventing consumers from finding out about products products recognised as safer than cigarettes and the industry from informing them in a responsible manner
  3. Pharmaceutical style product standards – requirements for consistent dosing (same puff always delivers the same amount of nicotine), pharmacokinetic testing, leak free refilling and post-market pharmacovigilance – which appear to be copied from medicinal regulation and are not achievable for the majority of existing products
  4. Refillables – provision to extend ban across EU if three Member States apply a ban
  5. National Governments’ ability to ban cross border sales and maintain status quo to classify e-cigarettes as medicinal products 
As a responsible industry, we remain committed to constructive engagement with the European Commission and Parliament to correct these issues in a mutually satisfactory manner. While a swift adoption of the TPD is regarded as an imperative, as an industry we believe it’s critical to have appropriate and proportional regulation and policy implementation capable of realising the public health benefits offered by e-cigarettes as a safer alternative to cigarettes.
 
We believe most of the above issues can be addressed by the prompt adoption of agreed Industry Standards (to ensure standards of product quality & safety) and an Advertising Code (to ensure all advertising is responsible and targeted only at smokers) – both of which are being progressed by the industry and are close to being finalised. 
 
10 Motives
BandZ srl
BLU s.r.l
Cigg-e Limited
Cigg-e Live
Decadent Vapours
Ecigarette Direct
Electric Zebra
Electronic cigarettes Ltd
Gamucci
Gower Enterprises Ltd
House of Liquid
iBreathe LTD
JAC Vapour Ltd
Joyetech
Mirage Cigarettes Ltd
Multicig
No-Match
Nome Dell Azienda
NUCIG Ltd
ROK Premium Electronic Cigarettes
Skycig
Smokers Angel
Socialites
TABlites
The Electronic Cigarette Company
Totally Wicked
VAEPE
Vapestick
Vapertrails Ltd
Victory Electronic Cigarettes Corp
VIP Electronic Cigarettes
VT Wholesale Ltd
Zandera Limited/E-Lites
 

When it comes to the TPD TVECA has no authority.

Yesterday, TVECA rocked the e-cig world when they wrote in a letter to MEPs, that they and their members support the current draft TPD in relation to electronic cigarettes and that although they had a few reservations, it was ultimately, “well done EU, we are fully behind you.”

This is the complete opposite to what the rest of the vaping community and industry are saying.

In their letter TVECA wrote that the “biggest share of the European electronic cigarettes industry” supports their position.  This is a bold statement, and if true, rather worrying.

However, if you look at the TVECA website this bold statement begins to unravel.  TVECA list only 16 individual member businesses, some very small, across the whole of the EU, and guess what?  11 of these 16 businesses are based in the Netherlands!  For the overwhelming majority of EU Member States TVECA has no member.

TVECA may argue that this is not a problem as their position and letter is also supported by a number of national trade associations from across the EU.  Again, if true this is very worrying.  One of the trade associations listed is CACE, the national trade association for the electronic cigarette industry in France.  Do CACE support the TVECA letter?  Not one bit of it.  It transpires that TVECA added CACE as a supporter without even showing them the letter; we can only assume that the same applies to all the other national trade associations cited in the TVECA letter.

Today CACE issued a statement that said:

“CACE disagrees with recent pronouncements TVECA, considering in particular Article 18 of the draft Directive tobacco as a preferred solution to the regulation of the market of electronic cigarettes in Europe. CACE here wants to assert its independence from the TVECA, whose orientations differ legitimate interests vapoteurs and French professional electronic cigarette.  In addition, the CACE is not a member of TVECA even if our association dialogue at European level, with all the actors involved in the draft Directive.”

CACE are an Industry organisation that on their website claims to represent 61 members (manufacturers and distributors), 58 commercial websites, nearly 241 specialty shops, 12,800 outlets representing more than 2,000 jobs and 1.5 million consumers.

TVECA is an American organization that allegedly fell out with another organization in the USA, namely SFATA, and so decamped to Europe.  Further inspection of their members sites show that the majority of their members are either flavour houses, or they sell nothing bigger than a basic eGo, (much like the tobacco companies that have joined the e-cig market), so the TPD is pretty much fine for them.  Having it amended to deal with the legitimate concerns of the majority of this industry and consumers would only increase their competition.  Far better to support a poor piece of legislation that will negatively impact their commercial rivals.

In the last week scientists and vapers from across the EU have made it clear that they cannot support the TPD in its current form.  We also understand that a letter signed by individual electronic cigarette companies stating their opposition to the TPD will be published this week.

In sending this letter TVECA have made a power grab for their own benefit, not the benefit of the majority of vapers who they clearly hold in contempt.  It is clear that TVECA want to be the only guys round the table negotiating the implementation of the TPD.

TVECA really do not speak on behalf of the “biggest share” of the electronic cigarette industry in Europe, they certainly do not speak for the public health community or the millions of vapers and their families.  MEPs have now got to decide whose side they will be on.

We hope that MEPs will see through TVECA and continue to stand up for public health and the rights of upwards of 12 million vapers throughout the EU.

We call upon the ENVI Committee to maintain its integrity and authority and vote against the tabled Trilogue changes.

On Wednesday, in accordance with the European Parliament’s Rule 70.5, the single vote on the revised Tobacco Products Directive (TPD) will take place in the Parliament’s Environment, Public Health, and Food Safety (ENVI) committee.

This will be the first time MEPs have had an opportunity to express a formal opinion on the TPD since the historic vote on the 8th of October last year.

As Martin Callanan MEP so clearly set out on these pages recently, a simple majority of ENVI committee members is needed for the committee’s consent on the negotiated text.

If the report is adopted in the ENVI committee with less than one-tenth of members voting against, (7 MEPs), the TPD will go to vote in plenary under Rule 138.

This will mean that the TPD will be subject to a single vote.

However, this could change if, before the drawing up of the final draft agenda, political groups or individual MEPs who together constitute one-tenth of all MEPs, (76 in total), request in writing that the TPD be open to amendment, in which case the Parliament’s President shall set a deadline for the tabling of amendments.

As vapers and scientists made clear last week, and as manufacturers will make clear this week, the TPD in its current incarnation is deeply flawed.  Clive Bates has drawn our attention to just one of these flaws on his excellent blog, and this is just one example drawn from a very long list.  We have arrived at this situation primarily because the current version of the TPD, and in particular Article 18, was drafted on the hoof, behind closed doors, and without any consultation with those who will be impacted by this directive.

Like many others, Save E-cigs has come to the conclusion that if Article 18 cannot be significantly amended, then it should be removed from the TPD.  Not all MEPs will wish to amend the TPD; some who previously campaigned on our behalf now believe that they have done all they can, and those who have always been against us are unlikely to support us now.  That said, a number of MEPs do want to at least try to have Article 18 amended.  Like us they see it as unworkable.  They recognise that it could lead to a ban on refillables, and that with a ban on certain currently available nicotine strengths, they worry that e-cigarettes may cease to be as effective and therefore will be seen as a less attractive alternative to smoking tobacco cigarettes.

Those MEPs who seek reform are supported by industry, the independent scientific/public health community, and most importantly, upwards of 12 million vapers from every corner of the European Union.

If any credibility is to be salvaged from this whole process, it is vital that these views are allowed to be heard in the European Parliament, even if ultimately they are voted down.  We, the ones who will have to live with the consequences of Article 18 should be given our opportunity to have our say and to have our arguments articulated by our democratically elected supporters in the European Parliament.

MEPs on the ENVI committee therefore have a wider obligation not only in ensuring they do not deny or make it harder for their colleagues to table amendments to the TPD if they so wish, but more importantly a duty to a very fundamental matter.  In October a majority of their MEP colleagues from across the political spectrum voted in favour of amendment 170.  It is therefore  their basic duty as members on the ENVI committee  to ensure that the wishes of the majority are reflected in their vote.  The TPD amendment that is in front of the ENVI Committee is significantly different  from amendment 170, and therefore no matter what individual members may feel personally or politically, the ENVI Committee can only, if it is to maintain its integrity and authority vote against the tabled Trilogue changes.

The easiest way for this to happen is for all members of the ENVI committee to vote unanimously to reject the TPD.  In laying aside their personal views on the TPD, ENVI members will make it easier for amendments to be tabled ahead of the final vote in plenary in March and will therefore be doing their colleagues and vapers across the EU a great service.

We urge all readers to contact members of the ENVI committee ahead of Wednesday’s vote asking them to vote reject the TPD.

You can find a full list ENVI committee members and their contact details here.

First joint declaration by European electronic cigarette user associations!

First joint declaration by European electronic cigarette user associations.

Original post on : http://www.aiduce.fr/premiere-declaration-commune-des-associations-europeennes-dutilisateurs-de-la-cigarette-electronique/

Together with AIDUCE, European e-cigarette user associations have come together to demand the removal from the Tobacco Products Directive of provisions that are incoherent and dangerous for public health. They ask that e-cigarette regulation be based on proper and objective research and not on unproven prejudice.

European-Letter_EN

Open letter, sent to the EU, signed by 15 Scientists, outlining why the TPD is scientifically flawed

This is an open letter, sent to the EU, signed by 15 Scientists, outlining why the TPD is scientifically flawed. The original letter is on website: http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/149-tpd-errors
Details
Created on Friday, 17 January 2014 11:47

 

Scientific Errors in the Tobacco Products Directive

A letter sent by scientists to the European Union

 

The scientific community is dedicated to support the need for appropriate interpretation of research on e-cigarettes and continues its efforts to provide proper and reliable information concerning e-cigarette regulation. Key scientists in the field of tobacco and e-cigarettes have sent today a letter to Health Commissioner Mr Tonio Borg and MEPs concerning the issue of e-cigarette regulation,explaining in detail and with references to medical studies the problems of the currently proposed regulation.

This is the letter sent to the EU.

 

Scientific Errors in the Tobacco Products Directive
January 16, 2014

Madam, Sir,

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 switch 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 similar 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, see 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 ultimatelytraditional tobacco consumption, as they mimic and normalize the action of smoking. 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 smokers 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 smoking-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) DawkinsL, CorcoranO. 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.