Electronic Cigarette Industry Trade Association

Tel : 01639 710 558

Email : support@ecita.org.uk

You are here

ECITA ISE: Chapter 1 A Brief History of the Electronic Cigarette Industry

04 : Chapter 1 A Brief History of the Electronic Cigarette Industry

Thursday, November 6, 2014

Introduction

Electronic Cigarettes (or ‘ecigs’) were first patented in the United States in 1963(1). Since 2006/7, ecigs have become progressively more widely available across the world, with millions of smokers now using these products – often entirely replacing traditional tobacco cigarettes. Despite such widespread use over so many years, no-one has been able to identify any substantial risk of harm, providing the existing regulations are complied with.

Figure 1 below shows an electronic cigarette in cross section. The cartridge contains a liquid – commonly referred to as ‘e-liquid’ – which is largely made up of propylene glycol (PG) or vegetable glycerine (VG) (more correctly referred to as 'glycerol'), nicotine (at low levels, ranging between 1.1% and 3.6%, which is well below the Control of Poisons and Explosives Precursors Regulations threshold of 7.5%(2), or 0% e-liquids), and some flavourings. PG is widely used in fog machines, and has been demonstrated to be non-toxic and non-carcinogenic. VG is widely used in both food and medical products.

Figure 1:

Electronic Cigarettes are relatively easy to use, since one simply puffs on it as one would on a tobacco cigarette. As the user draws on the device, the battery heats up the atomiser which vaporises the e-liquid. The vapour which is produced is drawn into the mouth as the user inhales, and delivers a sensation very similar to that produced by cigarettes. Indeed, this is one of the main reasons for the acceptability of the product to smokers, and a key function which currently licensed NRT products fail on. However, since there is no combustion, and nothing is burning, there is no actual smoke – producing deadly carcinogens – and no passive smoking risk. There is only vapour, similar to that produced by a fog machine. This means that electronic cigarettes are not subject to the smoking ban, since they produce no smoke. As ASH put it in a Briefing in March 2014:

“The fact that electronic cigarettes look similar to conventional cigarettes has been said to risk confusion as to their use in public places, such as on public transport. However, given that the most distinctive feature of cigarette smoking is the smell of the smoke, which travels rapidly, and that this is absent from electronic cigarette use, it is not clear how any such confusion would be sustained.”(3)

Nevertheless, we recognise the potential challenges for Trading Standards/Environmental Health Officers, and provide a simple checklist (at ANNEX II) which will allay concerns and assist officers in taking appropriate action when necessary against anyone breaking the law, whilst allowing consumers of electronic cigarettes to enjoy these products unmolested.

For more information about the diversity of electronic cigarette products, please see ANNEX III and for an explanation of some of the ‘vaping’ terminology, please see our Glossary of Terms at ANNEX IV.

The Electronic Cigarette Industry Trade Association (ECITA (EU) Ltd) was established in June 2010. Part of ECITA’s mission is to provide information and assistance to Trading Standards and other government regulators, to ensure compliance with the law across all the businesses in this sector, within an appropriate regulatory framework (supplied herein), under the General Product Safety Regulations (2005), and other relevant legislative statutes.

There has been considerable movement since 2012 in trying to make policy decisions about precisely how electronic cigarettes might be regulated in a different way to the existing framework. Some government bodies have tried to introduce medicines regulation, but without much success (see Legal Rulings and Opinions), and tobacco regulation would clearly be equally inappropriate for these products, which contain neither tobacco, nor involve combustion. There are early indications, however, that this is precisely the approach being suggested by the WHO, but many in Public Health are already raising objections to this. (See Electronic cigarettes: time for an accurate and evidence-based debate, published in Addiction, May 2014.)

During these uncertain times of regulatory flux, it is all the more important that the industry ensures that it is fully compliant with the existing regulations. We are fortunate in having some excellent provisions already in place, to ensure consumers are protected from potentially dangerous products, and can make a smooth transition away from smoking and into vaping. The various policy-making processes have identified some legitimate concerns, however, which we are taking action to address. This includes commissioning some specific toxicological research, as well as developing new testing protocols. We are working with the British Standards Institute to ensure that robust, recognised standards are introduced as soon as possible, to reinforce the work already undertaken by ECITA.  

The much-maligned nicotine has undergone something of a renaissance, since it has been shown that it is not the nicotine in tobacco products which is carcinogenic. Indeed, nicotine(4) is now regarded as so safe that NRT products are recommended for use in pregnancy, and are even handed out to school children. (This is not something which ECITA condones, since it can and does have disastrous consequences in the hands of children.(5))

Research published in The Archives of Toxicology in 2013(6)  indicates that the LD50 (the dose at which half of the sample of subjects would die) for nicotine may have been grossly misrepresented. The current estimate of LD50 is approximately 1mg/kg, which equates to a dose of 60mg to provide a toxic dose to an adult human. (It is important to bear in mind that nicotine users tend to build up a certain level of tolerance to nicotine.) The ultimate source of this toxicity data appears to be a textbook published in 1906, which referenced experiments conducted in the 1850s involving self-administration of nicotine by three German toxicology pioneers. However, Professor Bernd Mayer suggests:

“...a careful estimate suggests that the lower limit causing fatal outcomes is 0.5-1g of ingested nicotine, corresponding to an oral LD50 of 6.5-13mg/kg”

so it is between 6.5 and 13 times less toxic than originally thought. This is a better match with the animal data, as Mayer identifies, and certainly would be more plausible to the average nicotine user. Indeed, people have survived oral doses used in suicide attempts of up to “4g of pure nicotine.”

The first phase of our toxicological work has provided us with the evidence we needed to be able to issue revised CLP guidance, reducing the categories for the toxicity of nicotine for most concentrations of eliquids. This comes into force immediately in June 2015, since the transition phase is well underway, and the new CLP guidance is found in CHAPTER 4. The European Institutions are now engaged in an international process to try to reclassify nicotine under CLP, so this advice may be subject to change in the (relatively) near future.

Electronic cigarettes: Tobacco product, pharmaceutical product, or General Sales Product, by legal definition?

Tobacco products are very clearly defined in EU/UK law:

“Under the Tobacco Products Directive (2014/40/EU) 'tobacco products' means "products that can be consumed and consist, even partly, of tobacco, whether genetically modified or not;"”

Furthermore, this Directive sets out very clearly in the Chapter Titles that electronic cigarettes with nicotine are not regarded as tobacco products, but as 'related' products.

The vast majority of electronic cigarettes do not contain any tobacco. Those eliquids that do contain an element of tobacco flavouring are likely to be at below the LOQ (level of quantification) in scientific analysis, and inasmuch as perfumes containing tobacco absolute are not classified as ‘tobacco products’, there is a solid precedent for considering that even tobacco-flavoured e-juices are not even tobacco-flavoured e-juices are not even marginal tobacco products. (Presumably this is because tobacco absolute, like the tobacco leaf/essential oils used in e-liquid flavourings, are in and of themselves nicotine-free.)

The independent Electronic Cigarette Industry does not consider itself part of, or affiliated with, the Tobacco Industry, although in recent years, the Tobacco Industry has been entering this market. ECITA takes the view that there is room in this market for anyone wishing to sell electronic cigarette products, providing they do so in compliance with the appropriate legal requirements, and if the Tobacco Industry can demonstrate a real commitment to offering reduced harm alternatives to replace their traditional products, then this should be encouraged.

We are aware of the WHO’s intention to reclassify electronic cigarettes as tobacco products, but believe that the growing opposition to this counter-intuitive attitude, from various public health experts, and many government ministers, will help to see off this threat in due course. (See Electronic cigarettes: time for an accurate and evidence-based debate, published in Addiction, May 2014. )

The Pharmaceutical Industry’s products (medicines) are equally carefully defined in EU law, split into two limbs, as follows:

“[a)] any substance or combination of substances presented as having properties for treating or preventing disease in human beings.

[b)] any substance or combination of substances which may be  used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

This is confirmed and expanded upon in the ruling of the European Court of Justice (ECJ) of 15 November 2007 (C-319/05), in particular paragraphs 61 and 64 shown below:

“61. Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct or modify physiological functions […].
 
64. In those circumstances, and in order to preserve the effectiveness of that criterion, it is not sufficient that a product has properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease.”

The ECJ goes even further by stating that consideration of the potential risks related to the use of the product must be taken in light of Community Law, in particular Directive 2001/83 (paragraph 70, no.5 above). (See also Legal Rulings and Opinions.)

Therefore, we believe it is equally inappropriate – and unnecessary – to attempt to reclassify electronic cigarettes as medicines. The products are neither tobacco products, nor are they pharmaceutical products; they are consumer electronics, marketed as an alternative to smoking tobacco. Therefore, the only appropriate regulatory framework which can be legally applied to electronic cigarettes is consumer product regulation, such as the General Product Safety Regulations (2005) et al, enforced by Trading Standards Officers, or some other new consumer product regulation which may be introduced – although this will have to be carefully scrutinised for its proportionality and proper addressing of the legitimate concerns.

The EU’s revisions to the Tobacco Products Directive, which now include electronic cigarette products as “related products” in Article 20 (formerly Article 18), defines electronic cigarettes (in Article 2) as:

“‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges;”

We do not believe that this is an appropriate or useful definition. It is very sloppily constructed: in using the phrase ‘can be used’, this definition would capture a large range of products which have nothing to do with electronic cigarettes, nicotine, smoking, or tobacco whatsoever! Furthermore, this definition attempts (albeit unsuccessfully) to exclude electronic cigarette products without nicotine – an oversight with potentially very serious consequences for consumer protection.

We believe that a more accurate, relevant and useful definition would be:

‘Electronic cigarette’ means a product, or any component part thereof which may be sold separately, including cartridges, devices without cartridge, and liquid refills, that is intended to be used for inhalation of vapour which may or may not contain nicotine, via a mouth piece. Electronic cigarettes may be disposable and/or rechargeable, pre-filled with liquid, or refillable by means of a liquid refill.

ECITA continues to work with policy-makers at both Member State and EU level, to ensure that the disproportionate and potentially dangerous parts of Article 20 can be sufficiently mitigated during the implementation phase. Indeed, the UK Department of Health has ‘Observer status’ over the progression of BSI PAS 54115 towards publication, and has indicated their interest in using this standard to assist with implementation of the TPD requirements. PAS 54115 is scheduled for publication in mid-2015.

Alongside these efforts, the EU Tobacco Products Directive is now subject to Judicial Review at the European Court of Justice, following an application from Totally Wicked, a UK-based electronic cigarette manufacturer, and by consent from the Secretary of State.

The Control of Poisons and Explosives Precursors Regulations (2015)

The Control of Poisons and Explosives Precursors Regulations (2015) provide a framework for the protection of the public from genuinely poisonous products. The Regulations prohibit the sale of products classified as poisons, by those without appropriate authorisation, i.e. registered pharmacists, medical professionals, licensed agricultural product manufacturers, etc. Penalties are enforceable for those who breach these Regulations, as well as mechanisms for the immediate removal of such products from sale. Nicotine is exempted at concentrations below 7.5%.

This exemption reflects the fact that nicotine is a perfectly legitimate recreational substance, and sets out the necessary safety parameters for its use, and allows these products to fall within the CLP regulations. The exemption is clearly drafted with human consumption in mind. This provision has not been superseded by the introduction of electronic cigarettes to the market, and they sit comfortably within the current structure.

To attempt to effectively ban electronic cigarettes while leaving tobacco cigarettes widely available to consumers simply makes no sense. Both electronic cigarettes and tobacco cigarettes deliver relatively similar levels of nicotine – allowing for the varieties in each type of product – so to attempt to remove one from sale without impacting on the other would be a clear infringement of the rules governing fair trade and business enterprise. Notwithstanding that tobacco products are well protected in law, there is an inherent lack of coherence in the thought process which could suggest that electronic cigarettes should be removed from sale, not least because they pose no risk of serious harm to consumers, nor has any such risk been demonstrated to date. The same cannot be said of tobacco products. This probably goes some way to explaining why the European Parliament voted so clearly in October 2013 against medicinal regulation of electronic cigarettes.

The ECITA Industry Standard of Excellence

By offering the regulatory framework outlined herein for the effective self-regulation of the Electronic Cigarette Industry from within, with appropriate oversight from our regulators, Trading Standards and others, we hope to allay any fears of risk to public health and safety. We believe that our program of Internal Audits provides sufficient checks and balances not only to demonstrate due diligence, but to promote Excellent Business Practices across the sector.

ECITA membership is available to any company engaged in the manufacture and/or sale of electronic cigarette products registered in the European Union, subject to terms and conditions.

 

Footnotes

1 http://www.google.com/patents/US3200819

2 The Control of Poisons and Explosives Precursors Regulations (2015) http://www.legislation.gov.uk/uksi/2015/966/pdfs/uksi_20150966_en.pdf

3http://www.ash.org.uk/files/documents/ASH_715.pdf

4 Information regarding the safety of nicotine is available from:

http://www.tobaccoharmreduction.org/faq/nicotine.htm 

http://www.wired.com/science/discoveries/news/2007/06/nicotine

http://www.healthcentral.com/drdean/408/56968.html

5 Press releases:

a Mirror – Boy, 14, overdoses on nicotine given out at school
http://www.mirror.co.uk/news/2009/07/21/boy-14-overdoses-on-nicotine-gum...
b UPI.com – Boy, 14, overdoses on nicotine gum
http://www.upi.com/Top_News/2009/07/20/Boy-14-overdoses-on-nicotine-gum/...

6http://link.springer.com/article/10.1007%2Fs00204-013-1127-0/fulltext.html