15th July 2017

CPPD Module 11: E-cigarettes

Brush up on how the TRPRs affect the sale of e-cigarettes and vape pens in the UK


By Jane MacGregor
CTSI Lead Officer for Health
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Electronic cigarettes – also known as vapourisers or electronic nicotine delivery systems (ENDS) – are battery-powered devices that deliver nicotine by heating a solution of nicotine, flavouring, additives and propylene glycol and/ or vegetable glycerine (glycerol). They typically consist of a mouthpiece, a battery, and cartridge or tank containing the nicotine solution.

When a user sucks on the device, a sensor detects airflow; this activates a heating element – the ‘atomiser’ – which heats the liquid in the cartridge so that it evaporates. The vapour delivers the nicotine to the user. E-cigarettes were developed to mimic the action of smoking – including nicotine delivery – without the toxic effect of tobacco smoke.

When a person smokes a conventional cigarette, smoke is inhaled into the lungs and then exhaled. Smoke is also emitted from the burning tip of the cigarette, releasing toxins into the air. By contrast, there is no combustion involved in the use of e-cigarettes, so there is no smoke. Vapour is released into the air only when the user exhales. There are three main types of e-cigarette:

    1. ‘Cig-a-like’ products – the first generation of electronic cigarettes was designed to resemble tobacco originals, so sometimes have a light at the end, which glows when the user draws on the device. They consist of either non-rechargeable disposable models or an electronic cigarette kit that is rechargeable and includes replaceable pre-filled cartridges.
    2. ‘Tank’ models, also known as vape pens – a rechargeable electronic cigarette with a tank or reservoir that has to be filled with liquid nicotine. Tank models, which have become more common, allow the user to choose from a broader range of nicotine strengths and flavourings.
    3. ‘Mods’, or advanced personal vaporisers, are more complex tank models that can be manually customised by, for example, adjusting the voltage on the device.

From May 2016, the Tobacco Products Directive 2014/14/EU (Article 20) (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers, in order to ensure:

  • Minimum standards are enforced for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
  • An environment is built to protect children from starting to use these products
  • Information is given to consumers so they can make informed choices

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

In summary, the TRPRs:

  • Restrict e-cigarette tanks to a capacity of no more than 2ml
  • Restrict to 10ml the maximum volume of e-liquid for sale in one refill container
  • 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 producers of e-cigarettes and e-liquids to notify the Medicines and Health products Regulatory Agency (MHRA) before they can be sold

Regulation 31: Notifications
The regulations introduce the requirement for producers of e-cigarettes and refill containers to notify the MHRA before their products can be sold. From the definition of electronic cigarette and refill container, it follows that the TPD is only applicable to e-cigarettes that contain nicotine – or can be used with a nicotine-containing liquid – and refill containers with a nicotine-containing liquid.

So the TPD does not apply to disposable electronic cigarettes containing nicotine-free liquid (used for social reasons), or to cartridges that contain nicotine-free liquid. Furthermore, products can only be brought onto the market in the form of: a disposable electronic cigarette; a rechargeable electronic cigarette to be recharged with single-use cartridges; or a refillable e -cigarette possessing a tank to be refilled by means of a refill container.

A producer is anyone who manufactures or imports these products, or who rebrands any product as their own. The MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK. Producers must submit information about their products 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 any stocks of products that do not comply with the labelling and product composition requirements of the TPD. The TPD does not cover nicotine-containing products authorised as medicines. Details about licensing these products as medicines can be obtained from the MHRA.

Regulation 37: Labelling
A leaflet must be provided with each product, with information on the following:

  • Instructions for use and storage
  • Contraindications
  • Warnings for specific risk groups
  • Possible adverse effects
  • Addictiveness and toxicity
  • Contact details of the producer and – if they are not in a member state – a person within a member state
  • List of all ingredients
  • Indication of nicotine content and delivery dose
  • Batch number
  • Recommendation to keep out of the reach of children

In addition, a health warning – ‘This product contains nicotine, which is a highly addictive substance’ – has to be applied and fulfil certain criteria. It must:

  • Appear on the front and back surfaces of the unit packet and any container pack
  • Cover 30 per cent of the area of each of those surfaces, calculated in relation to the area of the surface concerned when the pack is closed
  • Be in black, helvetica bold type on a white background
  • Be in a font size that ensures the text occupies the greatest possible proportion of the surface area reserved for it
  • Appear at the centre of that area The principle underpinning the legislation is that consumers should receive the required information before they buy.

The supply of e-cigarettes and liquids is evolving, and a number of scenarios are explored below in relation to how packaging intersects with the provision of information.

  1. If the product is a bottle of e-liquid – with no further packaging, other than an information leafl et, attached to the bottle via a tag or other means – the labelling requirements must be applied to the bottle via a label, a pull-out label, or other means.
  2. If the product is a bottle of e-liquid, with an information leaflet placed within a cardboard box/ sleeve, then the box/sleeve is considered the smallest individual packaging. TPD labelling must be applied to the box/sleeve. The bottle does not have to carry this information, but producers will wish to include it to identify the product and ensure safe use.
  3. If the product is a multipack of two or more bottles of e-liquid , or e-liquid is included in a presentation box or starter kit – where the individual bottles are placed in a cardboard box/sleeve (as in point 2 ) – TPD labelling must be applied to the individual cardboard box/sleeve and each subsequent layer of packaging. Where the individual bottles not packaged and are aggregated in a multipack or presentation box, the multipack or presentation box would be considered the unit pack, and only the multipack or presentation box would require TPD labelling. Producers will wish to include information on the bottle to identify the product and ensure it can be used safely.
Sources: ASH briefing note MHRA guidance

Recent e-cig issues

The Department of Health, the Medicines and Healthcare products Regulatory Agency and CTSI gave the following responses to questions about e-cigarettes:

Q: Are the Tobacco and Related Products Regulations (TRPRs), which are specific to e-cigarttes, intended to replace the more general Classification, Labelling and Packaging (CLP) Regulations 2010?

A: Both the CLPs and TRPRs apply. The TRPRs require e-cigarettes and refill containers of nicotine solutions to be labelled with mandatory warnings and information. CLPs apply to nicotine solutions in the same way as they would for any chemical placed on the market in a consumer product. Products should be fully compliant with both laws.

Q: Must e-liquids be date marked?

A: There is no requirement in the TRPRs to give a date indication on e-liquids.

Q: Is it permissible for an e-cigarette to make reference to being eco-friendly?

A: No. We believe the use of ‘eco’ in the branding of e-cigarettes contravenes Regulation 38(3)(a),(b) and (e).

Q: Can e-cigarettes and refill containers include images of food on the label, or make reference to food in the name of the product or in a description of an ingredient?

A: Yes. Food or food ingredients may be used to describe the flavour of an e-liquid. The presentation of the product must not mislead the purchaser as to the true nature of the product, and it must be clear that the product is not a foodstuff.

Q: Must warnings be applied to refill containers that contain zero nicotine?

A: There are no requirements for refill containers that do not contain nicotine . However, the TRPRs apply to e-cigarettes that do not contain nicotine when sold.


MODULE 11: E-CIGARETTES AND THE TRPRs

Test your knowledge of e-cigarettes by completing this short questionnaire – scroll down to see the answers.

1. When did the Tobacco and Related Products Regulations come into force in theUK ?

2. What is the maximum capacity of an e-cigarette tank, in ml?

3. Fill in the blanks in the health warning: ‘This product contains , which is a highly substance.’

4. What is the maximum volume of e-liquid for sale in one refill container, in ml?

5. What is the maximum permitted strength of nicotine in an e-liquid, in mg/ml ?

6. Which organisation must a producer notify if they wish to supply e-cigarettes in the UK?

7. Are e-liquids required to be date marked?

8. Can food or food ingredients be used to describe the flavour of an e-liquid?

The online CPPD test for this module is now closed.

Answers:

1. 20 May 2016; 2. 2ml; 3. Nicotine Additive; 4. 10ml; 5. 20mg/ml; 6. MHRA; 7. No; 8. Yes