ECITA submits response to EU Public Consultation on the Tobacco Products Directive

ECITA Ltd Response to the Possible Revision of the Tobacco
Products Directive 2001/37/EC
Public Consultation Document
DG SANCO
2010

16th December 2010

To whom it may concern

We are writing on behalf of the Electronic Cigarette Industry Trade Association (ECITA) Ltd. There are a number of issues arising from your Public Consultation Document which we would like to address. For ease of reference, we shall respond to specific points as they occur in your document.

In the introduction, we are pleased to note your commitment to considering “new international, scientific and market developments” when reviewing the Directive. The “high level of health protection” you mention is at the very heart of ECITA’s philosophy, so we are confident that we can find some common ground.

II AREAS OF POSSIBLE CHANGE

1. SCOPE OF THE DIRECTIVE

1.1 Problem definition

We believe there may have been a fundamental misunderstanding about electronic cigarettes, in that these are not products which have come from either the Tobacco Industry, nor from the Pharmaceutical Industry. The Electronic Cigarette Industry is an entirely separate entity, but this does not mean that an entirely new regulatory framework is required, since there is already a perfect regulatory ‘fit’ for these products, as detailed below. Indeed, as we shall demonstrate, it is entirely incorrect to suggest that “there are no uniform conditions for regulating ENDS” where ENDS is used to mean electronic cigarettes.

1.2 Possible options

Under Option 2 – Extend the scope of the Directive, you suggest that “specific safety and quality requirements would be developed for ENDS.” Now, again, assuming that ‘ENDS’ is being used as a term to describe electronic cigarettes, this is precisely what ECITA has been doing to ensure the highest possible standards of product safety and quality. However, we do not believe that it requires an extension of the scope of the Directive, since electronic cigarettes are not tobacco products(1) (any more than nicotine patches or gum could be considered tobacco products, since they do not contain tobacco and are not produced by the Tobacco Industry) and, more importantly, electronic cigarettes are already comfortably covered by other EC legislation and regulations (see Annex 2).

1.3 Questions

So to answer your specific questions in this section:

1) Do you agree with the problem definition? If not, please provide explanations.

A: Not fully, since the problem definition overlooks the existing perfect regulatory fit, within the various applicable legal statutes(2) .

2) In your view, which option addresses the problem most effectively? and

3) Do you recommend any additional option that would effectively address the problem?

A: We suggest a modified option 2, to officially recognise the existing regulatory framework for electronic cigarettes, and further to acknowledge that electronic cigarettes are neither medicinal nor tobacco products, but are general consumer products requiring the same type of levels of CHIP labelling and hazard warnings as other household products which contain potentially dangerous chemicals, such as various cleaning products, for example, household bleach.

Every householder in Europe has potentially dangerous consumer products in their home, which is why we have legally-binding specific packaging and labelling requirements to ensure that the public can use these products safely. Electronic cigarettes are perhaps slightly different from cleaning products, insofar as they are designed to be inhaled, but the over-riding principle is the same, in terms of the appropriate regulations. In any event, all the genuinely scientific evidence to date demonstrates the inherent safety of e-smoking, especially as opposed to smoking tobacco products(3).

2. SMOKELESS TOBACCO PRODUCTS

Since these are an entirely different type of product to electronic cigarettes, we do not believe that it would be appropriate for us to comment on these. However, in terms of a genuine Tobacco Harm Reduction approach, many of the expert’s opinions and comments in Annex 1 will be as relevant to Smokeless Tobacco, as they are to electronic cigarette products.

3. CONSUMER INFORMATION

Again, this section relates almost exclusively to concerns about tobacco cigarette packaging, and is therefore not relevant to the Electronic Cigarette Industry. It would, therefore, be inappropriate for us to comment on the options discussed in this section. However, as indicated in section 1 above, ECITA recognises and promotes the importance of compliance with the relevant packaging and labelling requirements which are appropriate to electronic cigarette products, so as to ensure public health and safety.

4. REPORTING AND REGISTRATION OF INGREDIENTS

Although this section also focuses on tobacco products, rather than on electronic cigarettes, and is therefore outside our area of expertise, it does raise an interesting issue: you mention the difficulties in financing the “appropriate toxicological and addictiveness tests” for smoked tobacco products. We wonder why these are deemed necessary, since it has been well-documented in reliable scientific publications that smoking causes multiple diseases and premature death.

We believe that what is needed is a broadly-defined Tobacco Harm Reduction (THR) approach, not limited to tobacco products, or pharmaceutical interventions or therapies. In this way, consumers can mitigate the risks, providing policies are adopted to promote and support THR in as many forms as possible, so that smokers are made fully aware of the truth about their options. Many respected international experts share this view:

Dr Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force

“E-cigarettes would be a major part of the proposed harm reduction initiative, because they appear to satisfy the nicotine addiction and the habituation to the cigarette-handling ritual more effectively than any other product now on the market. For many current smokers, E-cigarettes may be the only low risk nicotine delivery product acceptable as a substitute for conventional cigarettes.”(4)

Professor Michael Siegel, MD, MPH
Department of Community Health Sciences, Boston University School of Public Health:

“...the valid question is not whether or not electronic cigarettes are safe. The question is whether or not electronic cigarettes are much safer than conventional ones. If they are, and if they help keep people off of the known highly toxic cigarette variety, then they could be a huge benefit to the public's health. We surely wouldn't want to pull them from the market, forcing vapers to return to the highly toxic conventional cigarettes, when these products may actually be saving their lives.”(5)

(Annex 1 below details some more of these opinions.)

5. REGULATION OF INGREDIENTS

This section also focuses on tobacco products, and the requirements for electronic cigarette ‘eliquid’ have been addressed at section 1. However, you mention that “during the process of burning majority of additives form substances that are carcinogenic, mutagenic and/or toxic for reproduction.”

It is well-documented that nicotine itself is not the problem, and indeed, you do specifically mention the ‘process of burning’ as being the cause of the problem. However, there is a wider issue which merits comment: ultimately, the ‘tobacco epidemic’ cannot be properly addressed unless alternatives are made widely and freely available, and combustible products are completely removed from sale. Since this is, at best, unlikely, it is all the more important that attractive alternatives such as electronic cigarettes be promoted through policy, rather than have their availability restricted.

6. ACCESS TO TOBACCO PRODUCTS

On the basis that we have outlined above the reasons why it is not appropriate to consider electronic cigarettes as ‘tobacco products’, since they do not contain tobacco and are not produced by the Tobacco Industry, this section appears at face value to be irrelevant to the Electronic Cigarette Industry. However, if the European Commission were to erroneously attempt to classify electronic cigarettes as tobacco products, and apply similar restrictions, we believe this would have a disastrous impact on the public health of European smokers(6) .

Conclusion

We trust that the European Commission will recognise and embrace the appropriate regulatory framework for electronic cigarettes detailed herein. Many thousands of smokers all over Europe and the rest of the world have already made the switch away from smoking tobacco products to using the infinitely less hazardous, non-combustible electronic cigarettes. We believe it would be an egregious misuse of power if the European Commission were to force these citizens back to using combustible tobacco products by restricting access to this revolutionary alternative.

Until THR is adopted and promoted as a policy objective, no real progress can be made in controlling the tobacco epidemic. It is essential that less hazardous alternatives be allowed to remain freely available.

ECITA has organised a petition to monitor support for electronic cigarettes, entitled ‘Freedom of Choice for Smokers’(7), which we intend to submit for the European Commission’s consideration early next year. (We have included the full text of the petition at Annex 3, for your information.) It has been well-supported – with thousands of signatures already - by a wide-range of petitioners, and we trust that you will give this your attention at the appropriate time.

Thank you for taking the time to consider our response to your Public Consultation.

For and on behalf of ECITA Ltd

Katherine Devlin
Operations Manager

Mike Ryan
Chairman

Simon Christou
Company Secretary

Peter Cole
Director

 
Annex 1:

Dr Joel Nitzkin, MD, MPH, DPA of the American Association of Public Health Physicians and Chair of the Tobacco Control Task Force:

“Most E-cigarette products are marketed as a substitute for conventional cigarettes for smokers who would like to continue nicotine use in a satisfying way, while virtually eliminating their exposure to products of combustion and other toxic substances (other than nicotine) in cigarette smoke. Given this purpose, the standard for comparison should be the health hazard posed by conventional cigarettes.”(8)

and

“Medical Science and Epidemiology: Even FDA’s own analysis shows E-cigarettes to have the same nicotine with about the same levels of trace contamination found in pharmaceutical products already approved by FDA. Propylene glycol, the other major ingredient is generally recognized as safe. The risk of death attributable to tobacco use from smokeless tobacco products is less than 5%, and, for some products, less than 0.1% the risk of death from conventional cigarettes. The risk of death from E-cigarettes, as best we can estimate from available data, should be about the same as for long term use of pharmaceutical nicotine replacement therapy (NRT) products, at the lower end of this range.”(9)

and

“... we (the AAPHP Task Force) learned some things we did not know before that both surprised us and put us in conflict with most of the rest of the public health and healthcare communities. The primary lessons were as follows:

1. Not all tobacco products are equally hazardous. With the possible exception of waterpipes, cigarettes present a risk of illness and death probably two to ten times greater than other combustible tobacco products, and 50 to 1000 times greater than non-combustible tobacco products (depending on the specific product).
2. Pharmaceutical smoking cessation products, even with the best of counselling and health education are spectacularly ineffective in achieving long term abstinence from cigarette smoking (only about 2% abstinent at 20 months post treatment).
3. The science is already completed to show that conventional cigarettes cannot be made significantly safer by any form of chemical manipulation.
4. Tobacco harm reduction – while loudly opposed by most health-related organizations is widely practiced in the form of long term use of pharmaceutical nicotine replacement therapy (NRT) products, and endorsed in the new law in terms of allowing for reduced exposure conventional cigarettes with no requirement for scientific proof that the reduced exposure will reduce risk.
5. Nicotine vaporizers, commonly referred to as electronic cigarettes or E-cigarettes appear to be as safe as the pharmaceutical NRT products and more likely than not, a low risk alternative to conventional cigarettes that will be more acceptable to more smokers than any other available product because of the manner in which they satisfy both the nicotine addiction and the habituation to the cigarette handling ritual.
6. On the basis of all of the above, we have concluded that the possibility exists for a new harm reduction initiative to be added to current tobacco control programming to substantially reduce illness and death among current smokers, hasten our progress in the direction of an eventually tobacco-free society and do so without increasing the numbers of teens experimenting with conventional cigarettes or other nicotine delivery products. This initiative would take the form of honestly and directly informing current smokers of the risk profiles of the various tobacco and tobacco-related products that they could buy where they buy their cigarettes, and at similar cost, and with E-cigarettes and snus to be among the available options. FDA regulation under the new FDA/Tobacco law could impose marketing restrictions on all these products to minimize use by minors.”(10)

 
Professor Michael Siegel, MD, MPH, Boston University School of Public Health:

“The decision about how to handle electronic cigarettes requires a careful consideration of the overall public health implications of the use of the product. One needs to weigh the clear benefits that this product appears to be having - the potential for a massive saving of lives from what could possibly be a breakthrough in smoking cessation technology - with the possible risks as well as the costs of forcing vapers to go back to conventional cigarette smoking (something which may have substantial public health costs).
...
To be sure, this is a challenging and complicated public health issue. But what it requires is not simplistic, ideological-based thinking. It requires taking a broad view and making a broad assessment of overall public health implications. It also requires objective and meaningful science, not just whether or not carcinogens are detectable in the product (something which we knew long before the FDA studied the product and something which is hardly relevant, since NRT products themselves contain detectable levels of carcinogens). It also requires consistency and rationality, and not blind adherence to any particular legal or policy ideology.
...
Most importantly, it requires balanced, meaningful, and honest communication with the media and with the public. How meaningful is it to tell the media that e-cigarettes contain carcinogens and not to tell those same reporters that nicotine replacement products also contain carcinogens. A reporter walking away from that press conference is going to get the wrong impression. Perhaps that's by design, but I think it's unfortunate.” (11)

Dr Ben Thomas, PhD, Professor of Toxicology at the University of Texas Health Science Center:

“In summary, of the four TSNAs evaluated by ANALYZE, only NAT was detected at low levels in the aerosol samples from the NJOY electronic cigarettes. NAT was tested by Hoffman et al (1984) and was shown to be non-toxic and non-carcinogenic in rats receiving a combined subcutaneous dose of up to 9mmol/kg. Based on the above, there is no evidence that carcinogenic TSNAs are present in the aerosol from NJOY electronic cigarettes. Thus, it is my conclusion that the TSNAs do not pose a health risk to the users of the electronic cigarettes distributed by NJOY.” (12)

Royal College of Physicians, London:

“Nicotine products are currently subject to grossly inconsistent regulation.
• Smoked tobacco, which is the most dangerous nicotine product, is freely available and the content and emissions of the product are virtually unregulated.
• It is now illegal to advertise smoking products in the UK, but cigarettes are available and easily accessible to smokers from a wide range of sources at all times of day and night.
• NRT products promoted with any health claim come under the control of the Medicines and Healthcare products Regulatory Agency (MHRA), and are tightly regulated.
• Non-tobacco nicotine products marketed with no health claims are currently unregulated*, so their purity and safety are unknown.
• Smokeless tobacco that is not intended to be sucked, including a number of products with significant hazard profiles, is unregulated and can be sold as freely as smoked tobacco.
• Supply of smokeless tobacco that is intended to be sucked, including the relatively low hazard Swedish snus products, is prohibited in the UK.
• This regulatory imbalance perpetuates smoked tobacco as the most freely available, affordable, effective and widely used nicotine delivery product.
• The current regulatory system therefore strongly favours the most dangerous tobacco products over those that are less hazardous, while imposing the strictest restrictions on medicinal nicotine.
• This regulatory approach needs to be reformed in the interests of public health.”(13)

* Please see Annex 2 for the current regulatory framework applicable to non-tobacco/non-medicinal nicotine products such as electronic cigarettes.

and

Summary
Cigarette smoking is powerfully addictive, and caused 100 million deaths in the 20th century. In the 21st century, if smoking trends persist as expected, one billion people will die from smoking tobacco. All of these deaths are preventable.

The Royal College of Physicians first called for radical policies to reduce the prevalence of smoking in 1962. Several of the policies recommended have since become validated, established international practice. However those measures, then and now, do not address the problem of smokers who cannot quit. The majority of the 150 million deaths from smoking expected worldwide in the next twenty years will occur in people who are smoking today. These people need help.

Compiled by leading experts in the field, this report makes the case for harm reduction strategies to protect smokers. It demonstrates that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.

Harm reduction is a fundamental component of many aspects of medicine and indeed everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking. This report makes the case for radical reform to the way that nicotine products are regulated and used in society. The ideas presented are controversial, and challenge many current and entrenched views in medicine and public health. The principles behind them have the potential to save millions of lives. They deserve consideration.(14)

Dr Brad Rodu, Professor of Medicine and Endowed Chair, Tobacco Harm Reduction Research, University of Louisville, Kentucky, School of Medicine:

“Many smokers are unable – or at least unwilling – to achieve cessation through complete nicotine and tobacco abstinence; they continue smoking despite the very real and obvious adverse health consequences. Conventional smoking cessation policies and programs generally present smokers with two unpleasant alternatives: quit, or die.

A third approach to smoking cessation, tobacco harm reduction, involves the use of alternative sources of nicotine, including modern smokeless tobacco products. A substantial body of research, much of it produced over the past decade, establishes the scientific and medical foundation for tobacco harm reduction using smokeless tobacco products.

This report provides a description of traditional and modern smokeless tobacco products, and of the prevalence of their use in the United States and Sweden. It reviews the epidemiologic evidence for low health risks associated with smokeless use, both in absolute terms and in comparison to the much higher risks of smoking. The report also describes evidence that smokeless tobacco has served as an effective substitute for cigarettes among Swedish men, who consequently have among the lowest smoking-related mortality rates in the developed world. The report documents the fact that extensive misinformation about ST products is widely available from ostensibly reputable sources, including governmental health agencies and major health organizations.

The American Council on Science and Health believes that strong support of tobacco harm reduction is fully consistent with its mission to promote sound science in regulation and in public policy, and to assist consumers in distinguishing real health threats from spurious health claims. As this report documents, there is a strong scientific and medical foundation for tobacco harm reduction, and it shows great potential as a public health strategy to help millions of smokers.”

and


“Formal cessation programs have existed for decades and have grown more complex and sophisticated, but relapse rates remain very high. According to a 2006 National Institutes of Health (NIH) Consensus Conference on Tobacco Use, "70 percent [of smokers] want to quit and 40 percent make a serious quit attempt each year, but fewer than 5 percent succeed in any given year"(15). The conference press release went on to make an astounding admission, "Effective tobacco cessation interventions are available and could double or triple quit rates..." This means that fewer than 15% of existing smokers, no more than 7 million, would be successful with maximum application of existing cessation strategies. The consensus statement failed to answer a vital question: What can be done for the remaining 40 million adult smokers? The rest of this report will review the scientific rationale and evidence for tobacco harm reduction as an alternative for these smokers.”

and

“Kozlowski et al. have argued persuasively that smokers have a fundamental right to accurate information about safer forms of tobacco use(16). The research group established the underlying rationale for the provision of this information, citing principles of the Universal Declaration of Human Rights, the doctrine of informed consent, and business ethics contract theory, under which companies have a moral obligation to inform customers about important information regarding their products.”

and

“Over the past 20 years, many public health and tobacco policy experts have argued that smokers have a fundamental right to accurate information about less hazardous products so that they can make informed choices if they are unable or unwilling to quit tobacco altogether. In 1984 Kozlowski commented on both the challenges and the potential of tobacco harm reduction, writing that "the use of less-hazardous tobacco, if prohibitionist impulses can be put aside, may have an important role in the treatment of the smoking and health problem..."(17).
...
One concern about tobacco harm reduction is that dissemination of information about less hazardous tobacco products might adversely affect public health if it creates new users. However, the risk/use equilibrium addresses this issue(18). If ST use is 50 to 100 times less hazardous than smoking, it would require 50 to 100 more ST users to reach the level of public harm produced by smoking. In other words, it would take 2.3 to 4.5 billion ST users to have the same death toll as 45 million American smokers do today, an impossible scenario in the U.S. population of 290 million people.”

and

“In 2003 Kozlowski et al expanded on the rationale that smokers are entitled to information about safer products, addressing concerns that provision of risk information might adversely affect public health: "Public health concerns should trump individual rights only when there is clear and convincing evidence of harm to society. Lacking that evidence, individual rights should prevail"(19).”

and

“It is not clear how Americans have become so confused about tobacco risks. But it is clear that misinformation about ST products is available in copious quantities from ostensibly reputable sources, including governmental health agencies and health-oriented organizations. Phillips et al have made some of the most pointed comments about this phenomenon:

"Certain health advocates believe it is acceptable to mislead people into making choices they would not otherwise make...Through the use of various tactics, advocates who oppose the use of ST as a harm reduction tool have managed to convince most people that the health risk from ST is several orders of magnitude greater than it really is. The primary tactic they use is making false or misleading scientific claims that suggest that all tobacco use is the same. . . . Apparently motivated by their hatred of all things tobacco, they are trying to convince people to not switch from an extremely unhealthy behavior to an alternative behavior that eliminates almost all of their risk"(20).

The tactic has worked in the U.S., as Americans, almost without exception and regardless of general and health education levels, believe that the risks from ST are similar to those from smoking. In particular, Americans incorrectly believe that switching from smoking to ST use will create a large increased risk for oral cancer. Phillips has characterized this popular misinformation as the "you might as well smoke" message, since it tells people that if they are using ST, they could switch to smoking with no increase in risk, while smokers considering switching to ST should not bother(21).”

and

“Government agencies, other organizations and members of the public health community have a moral obligation not to misinform smokers about products that have fewer risks than cigarettes. Nevertheless, researchers have exposed numerous cases of misinformation from governmental sources. For example, in 2003 Kozlowski and O'Connor criticized websites of the CDC and the Substance Abuse and Mental Health Services Administration for erroneously reporting that ST products were not safer than cigarettes, pointing out that "the misleading health information on ST fails to meet the government criteria against deception in research"(22).”

and

“In March 2004, Ken Boehm of the National Legal & Policy Center (NLPC), a non-profit organization committed to promoting open, accountable and ethical practices in government, filed a request under the Data Quality Act (DQA) for correction of a document from the National Institute of Aging (NIA) that contained misinformation regarding the relative risks of ST versus cigarettes. (This other DQA requests on ST can be seen at the U.S. Department of Health and Human Services website(23).) The request resulted in a change of wording from the original text:

"Some people think ST (chewing tobacco and snuff), pipes, and cigars are safer than cigarettes. They are not."

The revised wording from NIA was:

"Some people think ST (chewing tobacco and snuff), pipes, and cigars are safe. They are not."

The claim that ST products are not "safe" is a tactic that can be traced back to the 1986 Comprehensive Smokeless Tobacco Education Act, which required as one of three warnings on all ST products: "This product is not a safe alternative to cigarettes."

In 1995 Rodu criticized this warning as ludicrous and suggested that other consumer products like automobiles, lawnmowers, aspirin and red meat don't meet absolute criteria for safety(24). A decade later, Kozlowski and Edwards criticized this type of uninformative warning in a study entitled, "'Not safe' is not enough: smokers have a right to know more than there is no safe tobacco product"(25). These authors believe that smokers deserve more information: "The 'not safe' or 'not harmless' messages don't address the reality that some tobacco products are substantially safer than others... Saying tobacco 'isn't safe' isn't incorrect, but it isn't saying enough. Going beyond the no safe tobacco message to provide better information on the nature of risks from tobacco products and nicotine delivery systems is necessary to respect individual rights to health relevant information."”

and

“Tobacco harm reduction empowers smokers to gain control over the consequences of their nicotine addiction. At its simplest it is nonintrusive and solely educational, and therefore has a strong moral rationale. The strategy is cost-effective and accessible today to almost all smokers. But its implementation will require rethinking of conventional tobacco control policies and their premises.”(26)

Dr Carl V. Phillips:

“Background
Compared to smoking cigarettes, use of Western smokeless tobacco (ST) products is associated with a very small risk of life-threatening disease (with estimates in the range of a few percent of the risk from smoking, or even less). This means that smokers can realize substantial health benefits by switching to ST, an obvious substitute. But consumers and policy makers have little chance of learning that ST is much less dangerous than smoking because popular information provided by experts and advocates overstates the health risks from ST relative to cigarettes.
 
Results
We found that when any substantive information about the risk from ST is given, the risk is almost universally conflated with the risk from cigarettes. Accurate comparative risk information was quite rare, provided by only a handful of websites, all appearing low in our search results (i.e., of low popularity and thus unlikely to be found by someone searching for information). About 1/3 of the websites, including various authoritative entities, explicitly claimed that ST is as bad as or worse than cigarettes. Most of the other sites made statements that imply the risks are comparable.

Conclusion
Through these websites, and presumably other information provided by the same government, advocacy, and educational organizations, ST users are told, in effect, that they might as well switch to smoking if they like it a bit more. Smokers and policy makers are told there is no potential for harm reduction. These messages are clearly false and likely harmful, representing violations of ethical standards.”(27)

and

“Nicotine is so desirable to many people that when they are given only the options of consuming nicotine by smoking, with its high health costs, and not consuming nicotine at all, many opt for the former. Few smokers realize that there is a third choice: non-combustion nicotine sources, such as smokeless tobacco, electronic cigarettes, or pharmaceutical nicotine, which eliminate almost all the risk while still allowing consumption of nicotine. Widespread dissemination of misleading health claims is used to prevent smokers from learning about this lifesaving option, and to discourage opinion leaders from telling smokers the truth.

One common misleading claim is a risk-risk comparison that has not before been quantified: A smoker who would have eventually quit nicotine entirely, but learns the truth about low-risk alternatives, might switch to an alternative instead of quitting entirely, and thus might suffer a net increase in health risk. While this has mathematical face validity, a simple calculation of the tradeoff -- switching to lifelong low-risk nicotine use versus continuing to smoke until quitting -- shows that such net health costs are extremely unlikely and of trivial maximum magnitude. In particular, for the average smoker, smoking for just one more month before quitting causes greater health risk than switching to a low-risk nicotine source and never quitting it. Thus, discouraging a smoker, even one who would have quit entirely, from switching to a low-risk alternative is almost certainly more likely to kill him than it is to save him. Similarly, a strategy of waiting for better anti-smoking tools to be developed, rather than encouraging immediate tobacco harm reduction using current options, kills more smokers every month than it could possibly ever save.”(28)
 
Annex 2: Legal statutes relating to the regulation of electronic cigarette products

• The Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (29)
• Plugs and Sockets etc. (Safety) Regulations 1994 (30)
• Weights and Measures Regulations (31)
• Consumer Protection (Distance Selling) Regulations 2000 (32)
• Data Protection Act 1998 (33)
• Privacy and Electronic Communications (EC Directive) Regulations 2003 (34)

 
Annex 3:

ECITA petition: Freedom of Choice for Smokers

To: Members of the European Commission

We the undersigned petition the Members of the European Commission to: 'ensure that electronic cigarette products (and their use, hereinafter referred to as ‘vaping’) are classified correctly as General Sales Products and regulated appropriately for recreational purposes, rather than seek to define vaping as smoking, tobacco use or medical therapy.'

Electronic cigarettes are products which offer a genuine alternative for smokers which can satisfy the smoking habit without the significant and well-documented risks of smoking tobacco products. These life saving products have been widely available for over seven years and no serious harmful effects have been reported anywhere. They are considered by respected international harm reduction experts to be at least 99% safer than smoking. Many millions of smokers around the world have switched away from smoking tobacco products to using electronic cigarettes some or all of the time. (Some continue to smoke while also vaping, but this at least represents a reduction in their smoking.)

These products have been developed, manufactured, distributed and sold by the Electronic Cigarette Industry, and have no association with the Tobacco Industry or the Pharmaceutical Industry. We believe that inappropriate and/or disproportionate regulation will put the public at risk in several ways:

• by discouraging use, which will make an effective and attractive alternative to smoking as ineffective as NRT, such as gums and patches which are known to fail 93% in the longer term;
• by encouraging an unregulated black market; and
• by removing a reduced harm option for smokers who have no intention or desire to quit, forcing them to continue smoking, with the concomitant risk of passive smoking for those around them.

EC legislation already provides for suitable regulations for these products, with appropriate enforcement available for non-compliance. The UK Electronic Cigarette Industry has been working closely with its regulators, Trading Standards, to ensure compliance with the law as set out in these statutory instruments. Trading Standards agree that this is the correct and appropriate regulatory framework for these products.

The avoidance of inappropriate and/or disproportionate regulation is of considerable importance to the EC, as it is to the Member States of the EU. We are confident that you will seek to ensure that the correct classification is applied to these products. There is no need to create a new set of regulations for these new and innovative products, since they are sufficiently covered under existing legislation and regulations.

Proposals to classify such products as tobacco products or medicinal products are not based on fact, common sense, or the law. Electronic cigarettes involve no combustion, there is no tobacco, smoke or burning, so they cannot appropriately be classified as tobacco products. Equally, there is no sensible way to ‘bend’ the legal definition of a medicinal product to include a recreational product such as this, which neither claims to be a medicine, nor has any medicinal effect. Electronic cigarettes do not cure tobacco or nicotine addiction; rather they provide the user with a much safer way of continuing to use nicotine.

Sale of these products in the EU is already covered by the GPSR 2005, CHIP standards (for packaging and labeling), CE mark regulations and Plugs and Sockets etc. (Safety) Regulations 1994, et al. The vast majority of electronic cigarette retailers already have policies in place to ensure that there are no sales to minors. We expect this to become standard practice across the industry.

Nicotine is not a controlled substance. On the contrary, it is readily available all over the EU. We suggest that making a legal action illegal, or regulating products like these out of existence with deliberately burdensome and unachievable regulation, because of moral judgements, misinformation or confusion with something perceived to be undesirable, is unjustifiable and morally corrupt.

Vaping (using an ecig) is a recreational alternative to smoking which should be regulated and enforced appropriately. Adult citizens can make their own informed decisions about the options available to them, i.e. smoking, medicinal interventions such as NRT, or recreational nicotine from using electronic cigarettes.

Sincerely,

The Undersigned


References:

1 ECITA blog, US Court of Appeals Rules Against FDA, Dec 8th 2010
http://ukvapers.com/...es-against-fda/

2 ECITA website, Regulations
http://www.ecita.org.uk/regs.html

3 ECITA forum, News and Research, Scientific Research into Electronic Cigarettes and e-smoking
http://www.ecita.org...x.php?board=7.0, and

ECITA forum, Expert Opinions, Professor Michael Siegel
http://www.ecita.org....php?topic=61.0

4 “Citizen Petition to reclassify E-cigarettes from “drug-device combination” to “tobacco product”, J.L. Nitzkin, MD, MPH, DPA, February 7, 2010
http://www.aaphp.org...DAPetition1.pdf

5 “The Rest of the Story: Tobacco News Analysis and Commentary – Tobacco-Specific Carcinogens Found in Nicotine Replacement Products; Will Anti-Smoking Groups Call for Removal of these Products from the Market?” by Professor Michael Siegel, 22 July 2009
http://tobaccoanalys...s-found-in.html

6 “American Medical Association Not Sure Smoking is Any Worse than Using Electronic Cigarettes” by Professor Michael Siegel, 17 June 2010
http://tobaccoanalys...18_archive.html

7 ECITA’s petition, Freedom of Choice for Smokers
http://www.petitiono...m/petition.html

8 “Citizen Petition to reclassify E-cigarettes from “drug-device combination” to “tobacco product”, J.L. Nitzkin, MD, MPH, DPA, February 7, 2010 http://www.aaphp.org...DAPetition1.pdf

9 “AAPHP E-cigarette Petitions to FDA – Actions Requested and Justification”, J.L. Nitzkin, MD, MPH, DPA, February 7, 2010
http://www.aaphp.org...tionSummary.pdf

10 “AAPHP Tobacco Policy: Lessons Learned 2007-2009 and Current Policy Orientation”, J.L. Nitzkin, MD, MPH, DPA, February 7, 2010 http://www.aaphp.org...sonsLearned.pdf

11 “The Rest of the Story: Tobacco News Analysis and Commentary – Tobacco-Specific Carcinogens Found in Nicotine Replacement Products; Will Anti-Smoking Groups Call for Removal of these Products from the Market?” by Professor Michael Siegel, 22 July 2009
http://tobaccoanalys...s-found-in.html

12 Extracts from Court trial bundle in Civil Case No. 09-771 (RJL) between Smoking Everywhere, Inc., and Sottera, Inc., d/b/a/ NJOY v. U.S. Food and Drug Administration, January 14, 2010
http://www.aaphp.org...tion/B1-B53.pdf

13 and 14 “Ending tobacco smoking in Britain: Radical strategies for prevention and harm reduction in nicotine addiction”, Royal College of Physicians, London, Tobacco Advisory Group, September 2008
http://bookshop.rcpl...5bf06597623.pdf

15 National Institute of Health, “State-of-the-Science Statement on Tobacco Use: Prevention, Cessation and Control”, June 12-14,2006
http://www.webcitati.../1477-7517-3-37

16 Kozlowski, L.T. et al, “Harm reduction, public health, and human rights: Smokers have a right to be informed of significant harm reduction options”, October 2001
http://ntr.oxfordjou...t/4/Suppl_2/S55, and

Kozlowski, L.T. et al, “Apply federal research rules on deception to misleading health information: an example on smokeless tobacco and cigarettes”, 2003
http://www.ncbi.nlm....pubmed/12766212, and

Kozlowski, L.T. et al, ““Not safe” is not enough: smokers have a right to know more than there is no safe tobacco product”, 2005
http://www.ncbi.nlm....pubmed/16046699

17 Kozlowski, L.T. et al, “Less-Hazardous Tobacco Use as a Treatment for the “Smoking and Health” Problem”, 1984
http://tobaccodocume...28027-8038.html

18 Kozlowski, L.T. et al, “Applying the risk/use equilibrium: use medicinal nicotine now for harm reduction”, 2001
http://tobaccocontro...ontent/10/3/201

19 Kozlowski, L.T. et al, “Some practical points on harm reduction: what to tell your lawmaker and what to tell your brother about Swedish snus”, 2003
http://tobaccocontro...ontent/12/4/372

20 Phillips, C.V. et al, “Deconstructing anti-harm-reduction metaphors; mortality risk from falls and other traumatic injuries compared to smokeless tobacco use”, 2006
http://www.harmreduc.../content/3/1/15

21 Phillips, C.V. et al, “You might as well smoke: the misleading and harmful public message about smokeless tobacco”, 2005
http://www.biomedcen.../1471-2458/5/31

22 Kozlowski, L.T. et al, “Apply federal research rules on deception to misleading health information: an example on smokeless tobacco and cigarettes”, 2003
http://www.ncbi.nlm....pubmed/12766212

23 United States Department of Health & Human Services, Information Requests for Corrections and HHS’ Responses, item 13: NIH – Smokeless Tobacco, “The National Institute of Aging, NIH received a request from the National Legal and Policy Center on March 17, 2004 concerning the dissemination of information on smokeless tobacco. NIH responded to the request on June 29, 2004” http://www.webcitati.../1477-7517-3-37

24 Rodu, B., For Smokers Only: How Smokeless Tobacco Can Save Your Life. Sulzburger and Graham, New York; 1995.

25 Kozlowski, L.T. et al, ““Not safe” is not enough: smokers have a right to know more than there is no safe tobacco product”, 2005
http://www.ncbi.nlm....pubmed/16046699

26 Rodu, B. and Godshall, W.T., “Tobacco harm reduction: an alternative cessation strategy for inveterate smokers”, 2006
http://www.harmreduc.../content/3/1/37

27 Phillips, C.V. et al, “You might as well smoke: the misleading and harmful public message about smokeless tobacco”, 2005
http://www.biomedcen.../1471-2458/5/31

28 Phillips, C.V., “Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments”, 2009
http://www.harmreduc.../content/6/1/29

29 The Chemicals (Hazard Information and Packaging for Supply) Regulations 2009
http://www.legislati...6/contents/made

30 Plugs and Sockets etc. (Safety) Regulations 1994
http://www.berr.gov....ety-regulations

31 Weights and Measures Regulations
http://www.gbcshop.r...re/RTI/GIGI.pdf

32 Consumer Protection (Distance Selling) Regulations 2000
http://www.legislati...4/contents/made

33 Data Protection Act 1998
http://www.legislati...998/29/contents

34 Privacy and Electronic Communications (EC Directive) Regulations 2003
http://www.legislati...6/contents/made