E-cigarettes

E-cigarettes in Europe

General Introduction

Electronic cigarettes, e-cigarettes or ENDS (electronic nicotine delivery systems) are battery operated, vapour inhaler devices. They are used to vaporise and deliver a chemical mixture typically composed of propylene glycol, flavouring agents and nicotine; although non-nicotine options are also available. Some e-cigarettes are disposable and some are rechargeable[5]. Throughout this document, we will refer to these products as e-cigarettes.

The e-cigarette was developed as an alternative to traditional tobacco products. While a traditional cigarette is lit (for example by a lighter or a match) an e-cigarette is generally heated via the battery although products are emerging which have no electronic features and are charged with compressed air instead. A traditional cigarette contains tobacco; the vast majority of e-cigarettes do not. However, the technology is developing rapidly and there are now some products on the market which are capable of containing tobacco as part of the mixture that is vaporised by the e-cigarette. While some initial e-cigarettes adopted the form and look of a traditional tobacco cigarette, as the market develops, there is an increasing range of shapes, sizes and colours of e-cigarettes available.

E-cigarettes are not considered the same as licensed Nicotine Replacement Therapy. However, some specific e-cigarette products could be licensed as nicotine-containing products in the future if they applied for, and were granted, a medicines licence. One product, which contains compressed air rather than a heating element, has recently been successful in applying for a medicines licence in the UK[6]. Nicotine Replacement therapy is on the World Health Organisation’s list of essential medicines[7] and mainly comes in the form of patches, gum or inhalators. They have longstanding safety and effectiveness profiles and almost exclusively contain nicotine. Nicotine replacement therapy can be bought directly from shops or chemists or can be provided on prescription. In the UK, Nicotine Replacement Therapy products are granted a medicines licence from the Medicines and Healthcare Products Regulatory Agency after a rigorous testing process. If an e-cigarette manufacturer wanted their product to become a licensed nicotine-containing product, they would have to apply to the Medicines and Healthcare products Regulatory Agency. The options in the consultation paper are therefore concerned with regulating non-medicinal e-cigarettes only.

E-cigarettes have been on the market for less than a decade but there has been a significant increase in availability and take up of these products in recent years. In response to a need for regulation of these products across Europe, the recently revised European Tobacco Products Directive[10] set a Framework for the regulation of e-cigarettes, which will be implemented across the UK by May 2016. Under the terms of the European Directive, e-cigarettes that do not voluntarily seek a medicines licence will continue to be regulated as consumer products but with a range of additional safeguards for consumers. These regulatory safeguards include:

  • a limitation on the nicotine content;
  • a requirement for manufacturers and importers to report on ingredients in and emissions resulting from the use of e-cigarettes and provide toxicological data;
  • a requirement for the provision of information to consumers, including a health warning on packaging; and
  • restrictions on advertising and promotion with a cross-border impact, including on TV, radio, the internet and events sponsorship.

There are a number of areas that the European Directive does not regulate. These include certain domestic advertising (such as billboards, leaflets and posters), whether to restrict flavours, whether to ban use in certain areas in line with smoke-free legislation and whether to implement a minimum age for sale or use.

Debate

There is much debate amongst academics about the potential benefit and risk of e-cigarettes. The main points of the debate can be set out in three key themes: safety, usefulness as a quitting tool and impact on tobacco control efforts.

Safety

E-cigarettes are relatively new products and it will take some time before we can properly understand the impacts of their use on health (for individual users and for the wider population). Until the European Directive comes into force they are subject to very little regulation.

There are uncertainties about safety. It will take some time to monitor the long-term effects on people who use them and on bystanders exposed to second-hand vapour. Even with the safety regulations introduced by the European Directive, adverse health impacts may come to light over time. For example, we do not know what effects there might be from long-term inhalation of nicotine and the other permitted ingredients in e-cigarettes.

While there is widespread agreement that these products present much less risk for users and bystanders than traditional combustible tobacco products, it is not possible to say that they are risk free.

Role in stopping smoking and harm reduction

There is on-going debate over the potential value of e-cigarettes as aids to help people quit smoking. There is some evidence from former smokers that e-cigarettes have helped them quit and they may especially help smokers who have been unable to quit with traditional Nicotine Replacement Therapy. However, the evidence is limited and more research is needed which follows individuals over time to understand the role of e-cigarettes as quitting aids, and whether they help people to stop smoking over the long term. There is concern around dual use, for example, in terms of whether some people who smoke tobacco and use e-cigarettes may be less motivated to quit.

Tobacco control and renormalisation of smoking behaviours

Protecting young people has always been at the core of Scottish Government tobacco policies and will continue to guide us through our considerations for policy options on e-cigarettes. While the Scottish Government remains open-minded on the potential benefits of these products to current smokers, we need to ensure that they are regulated in a way which limits their attractiveness and accessibility to non-smokers, and in particular, to young people.

A great deal has been achieved through efforts to reduce exposure to tobacco products and smoking behaviours such as legislation to ban the advertising and display of tobacco, the ban on smoking in enclosed public spaces and campaigns to raise awareness about the dangers of smoking.

There is real concern that a possible modelling of smoking behaviours can occur as the use of e-cigarettes mimics the use of tobacco and may undermine tobacco control efforts. Some fear that an unintended consequence of the use of e-cigarettes (and particularly consequent nicotine addiction) could lead to tobacco use amongst non-smokers, particularly young people. Indeed the Parliament and Council of Europe set out in the Tobacco Products Directive that ‘electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalise the action of smoking'[11]. Given the addictive nature of nicotine and the clear and well established health harms of tobacco, this is a risk that the Scottish Government must carefully consider.

Age restriction for e-cigarettes

There is currently no restriction on the age that a young person can purchase an e-cigarette in Scotland. We know that nicotine is extremely addictive and evidence for tobacco has shown that the younger an individual starts to smoke, the more likely they are to be an adult smoker, the heavier they are likely to smoke during adulthood and the more likely they are to fall ill and die early as a result of smoking.[12]

As nicotine is the addictive component of tobacco, it is reasonable to assume that the younger an individual becomes addicted to nicotine through e-cigarette use, the longer the addiction could last.

There has been co-operation across retailers and manufacturers to implement a voluntary age-restriction on the sale of e-cigarettes to adults aged 18 and over. Earlier this year the Electronic Cigarette Industry Trade Association welcomed the UK Government’s announcement that it would introduce an age restriction[13]. However, there is evidence that the voluntary trade practice is not preventing young people from obtaining e-cigarettes.

Evidence about rates of use and access by young people is limited but improving. In Scotland, we will have the first robust data on under-18 e-cigarette use in November 2014.[14] A number of surveys already show that a small proportion of young people have tried or use e-cigarettes, typically regular tobacco smokers. [15]

An e-cigarette test-purchasing exercise in England also found that of 574 visits made by young people in March 2014, successful purchases were made by a child on 227 occasions (40%), despite 80% of the products purchased carrying an age-restriction warning[16]. While we recognise that the evidence base for e-cigarette use continues to develop, there is a clear indication that young people are accessing e-cigarettes which have either been purchased by themselves or provided by someone else.

Due to the addictive nature of nicotine and the risk of promoting smoking behaviours, the Scottish Government believes it is appropriate to introduce legislation that will restrict children and young people’s access to e-cigarettes and refills. This would bring the sale of e-cigarettes into line with other age-restricted products such as alcohol, tobacco and solvents. Similar action is being progressed in England, Wales and Northern Ireland.

Limited exemptions may apply to e-cigarette devices which become licensed as a medicinal product. Age restrictions for these products would be a matter for the Medicines and Healthcare products Regulatory Agency.

If an age restriction were introduced, proof of age requirements would be consistent with those for other age-restricted goods in Scotland. These include a passport, a photocard driving licence or a photographic identity card bearing the National Proof of Age Standards Scheme hologram such as the Young Scot National Entitlement Card[17].

In line with tobacco sales legislation, we propose that all sales of e-cigarettes and e-cigarette refills from self-service vending machines should be banned. This is because proof of age cannot be verified.

The Tobacco Products Directive 2014/14/EU (TPD)

The Tobacco Products Directive 2014/14/EU (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) from May 2016. MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20.

The TPD introduced new rules which ensure:

  • minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
  • that information is provided to consumers so that they can make informed choices
    an environment that protects children from starting to use these products.

The new requirements:

  • restrict e-cigarette tanks to a capacity of no more than 2ml
  • restrict the maximum volume of e-liquid for sale in one refill container to 10ml
  • restrict e-liquids to a nicotine strength of no more than 20mg/ml
  • require nicotine-containing products or their packaging to be child-resistant and tamper evident
  • ban certain ingredients including colourings, caffeine and taurine
  • include new labelling requirements and warnings
  • require all e-cigarettes and e-liquids be notified to MHRA before they can be sold

Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card reporting system.

Key terms

The definitions of products that are subject to the new regulations are set out below.

‘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. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore e-cigarette products such as disposable units and tanks will require a notification; however e-cigarette equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.

Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.

‘Refill container’ means a receptacle that holds a nicotine-containing liquid, which can be used to refill an electronic cigarette. These are more commonly known as e-liquids.

Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the TPD and do not have to meet its requirements. These products will continue to be regulated under the General Product Safety Regulations.

UK and Europe

The UK Tobacco and Related Products Regulations 2016 implement the TPD in the UK, and came into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

The regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to MHRA through a European Common Entry Gate (EU-CEG) notification portal.

Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers had until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.

The TPD does not cover nicotine-containing products that are authorised as medicines.

Under the TPD, it is the responsibility of the producer to ensure that their products comply with the TPD requirements.

Advice for producers: Putting a new product into the UK market

Producers of new e-cigarette and refill container products must submit a notification to MHRA six months before they intend to put their product on the UK market. Once your notification has been published in the list on our website below, you can launch your product in the UK. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the UK market.

A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.

If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.

Advice for producers: Products already in the UK market

Producers of all e-cigarettes and refill containers that are covered by the TPD and were on the market before 20 May 2016 had until 20 November 2016 to submit a notification to MHRA.

Reporting safety concerns

In the UK, E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify the MHRA by email to TPDsafety@mhra.gov.uk.

Trading Standards bodies have enforcement responsibilities under the legislation and MHRA works with them to ensure acceptable standards of safety.

Labelling and leaflets

UK Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products.

One interpretation of Article 20(4) of the Tobacco Products Directive (TPD) is that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid. Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’. For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’.

This advice only applies to product labels, and a full list of ingredients in the flavouring must be included in notifications through the EU-CEG.

The TPD also requires that packs include an information leaflet about safe use of the product. We encourage you to ensure your leaflets include appropriate advice on product storage, particularly on how to ensure the battery does not malfunction.

Where all the required leaflet information can fit on the unit pack and other labelling within the pack without loss of legibility to the consumer, our interpretation of the TPD is that the packaging can be considered to include the leaflet, and a separate leaflet insert is not required.

Additional statutory labelling requirements may also apply, such as the European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP).

If your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘this product contains nicotine which is a highly addictive substance’ must still be applied. To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. The warning statement should be included on all notified e-cigarette products.

Advice for retailers

If you sell e-cigarettes and/or refill containers by retail to the general public, you need to be aware of the transition periods for implementation of the new rules:

  • On 20 May 2017: You will need to remove from sale any remaining stocks of products that do not comply with the TPD.
  • From 20 May 2017: When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Submitted Products.

If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you.

Are you also a producer?

As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product.

A producer is anyone who manufactures or imports e-cigarette or refill container products and anyone who re-brands them as their own. If you qualify as a producer, please see the transition period guidance for producers above.

If you import or re-brand products, check with your supplier whether they have already made a UK notification for the specific product you sell. If they have done so, you do not need to submit a duplicate notification.

Nicotine Base Liquid

The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product).

The requirements do not apply to ‘trade sales’ i.e. where you are selling industrial quantities to another business and the sale is not directed to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.

Cross Border Sales

You need to register your business if you supply e-cigarette products via cross-border distance sales, for example online sales. This applies to:

– businesses established in the UK selling e-cigarettes and / or refill containers to consumers in another EEA state (European Economic Area – the 28 EU Member States plus Iceland, Liechtenstein and Norway)
– businesses established in the EEA or third country selling to UK consumers. Business to business sales, that is sales not direct to consumers, do not need to be registered.

Registration is a legal requirement under the TPD. Without confirmation of registration businesses must not supply a relevant product to a consumer via a cross-border distance sale. The UK notification requirement applies to products supplied to UK consumers via a cross-border sale.

Public Health England have uploaded a list of EEA Member States that have either confirmed they are permitting cross-border distance sales of e-cigarettes and/or tobacco products or are yet to confirm domestic rules in this area, and a list of registered retailers. All other Member States have banned cross-border distance sales, and it would contravene the law to trade in those countries. Businesses who intend to trade in countries where the sales confirmation, registration website or contact details are yet to be confirmed (TBC) are advised to contact the national authorities before commencing supply.

Notification

The format and content of notifications are set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.

Details of the information notifications are required to contain are set out by the Commission in the Data Dictionary.

Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.

The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.

Domestic advertising and promotion of e-cigarettes

The role of advertising and promotion has long been understood as contributing to the take up of tobacco use. A well-established evidence base has underpinned a range of legislative measures to protect young people from exposure to tobacco advertising.

The European Tobacco Products Directive[23] recognises the need for action here. By May 2016, certain advertising and promotion of e-cigarettes will be banned. This includes:

  • Telecommunications (communication over a distance by cable, telegraph, telephone, or broadcasting)
  • Radio
  • Internet
  • Most publications (e.g. newspapers)
  • Events marketing with a cross-border effect (such as televised sporting events)

While the Tobacco Products Directive does not cover purely domestic forms of advertising, it does encourage Member States to consider regulation within their own jurisdiction.

This could include:

  • Bill boards;
  • Leafleting;
  • Brand-stretching (the process of using an existing brand name for new products or services that may not seem related);
  • Free distribution (marketing a product by giving it away free);
  • Nominal pricing (marketing a product by selling it at a low price);
  • Point of sale advertising (advertising for products and services at the places where they are bought); and
  • Events sponsorship within a purely domestic setting.

Although public health experts remain divided on many of the issues that relate to e-cigarettes, there appears to be broad consensus that advertising and marketing of these products should not be aimed at young people[24] [25] . However, some have argued that it is unworkable to distinguish between advertising aimed at young people and adults or between smokers and non-smokers. Others have argued that a total ban on the advertising and promotion of e-cigarettes would restrict the availability of information about, and the accessibility of e-cigarettes for, current smokers which could then reduce the likelihood that they will use e-cigarettes as a cessation tool or reducing their tobacco use.

Resources

Notes

5. https://www.ashscotland.org.uk/media/6093/E-cigarettesbriefing.pdf

6. https://www.nicoventures.co.uk/announcing-voke-safer-alternative-smoking-licensed-medicines-and-healthcare-products-regulatory

7. https://apps.who.int/iris/bitstream/10665/93142/1/EML_18_eng.pdf?ua=1

8. Calculations are by ASH. They applied the proportions of e-cigarette use by smoking status in the 2014 YouGov survey to the most recent available ONS mid-year GB population estimates (2012).

9. www.smoinginengland.info

10. The Tobacco Products Directive (2014/40/EU)

11. Tobacco Products Directive (2014/40/EU

12. https://www.rcplondon.ac.uk/sites/default/files/documents/passive-smoking-and-children.pdf

13. https://www.bbc.co.uk/news/uk-wales-27908026

14. From the Scottish Adolescent Lifestyle and Substance Use Survey

15. Although they vary in reliability, a few UK surveys provide an indication of likely levels of youth use and experimentation: Hughes, K. et al. (2014) E‐cigarette access among young people in Cheshire and Merseyside; ASH Scotland (2014) Young people and e-cigarettes in Scotland. Report on a survey of young people; ASH Wales (2014) Young People and the Use of E-cigarettes in Wales

16. Trading Standards Institute (2014) Youth Access to E-cigarettes and Associated Products. Report for Public Health England

17. https://www.pass-scheme.org.uk/card-suppliers/

22. de Andrade, M. et al, G (2013a). The Marketing of E-cigarettes. A report for Cancer Research UK. (https://www.cancerresearchuk.org/prod_consump/groups/cr_common/@nre/@pol/documents/generalcontent/cr_115991.pdf ) Other analyses undertaken in the USA include: Grana, R.A. and Ling, P.M (2014) “Smoking Revolution”. A Content Analysis of Electronic (Cigarette Retail Websites, American Journal of Preventive Medicine 46(4): 395-403. (https://www.ncbi.nlm.nih.gov/pubmed/24650842); Gateway to Addiction? A survey of popular electronic manufacturers and targeted marketing to youth (2014) (Report for several US Senators) (https://democrats.energycommerce.house.gov/sites/default/files/documents/Report-E-Cigarettes-Youth-Marketing-Gateway-To-Addiction-2014-4-14.pdf); Legacy (2014) Vaporized. E-cigarettes, Advertising and Youth. (https://legacyforhealth.org/content/download/4542/63436/version/1/file/LEG-Vaporized-E-cig_Report-May2014.pdf)

23. Tobacco Products Directive (2014/40/EU

24. public-health expert letter to WHO 2

25. public health expert – letter to WHO 1

1 thought on “E-cigarettes”

  1. The independent review of the evidence for standardised packaging of tobacco products, in the UK, reiterated that pro-smoking imagery and role modelling contributes to smoking normalisation. This is relevant to our considerations for e-cigarettes because their use mimics smoking behaviour. There is also concern that the marketing of e-cigarettes can suggest that people should only quit tobacco use, inferring that nicotine addiction in itself is of no concern.

    Formal analysis of the content of websites, adverts and promotional materials (including a study in the UK commissioned by Cancer Research UK), provides evidence that some e-cigarette advertising is specifically aimed at a young audience.

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