E-Cigarettes
E-cigarette TPD Compliance Requirements
Nicotine Restrictions
Toxicological Risk Assessment (TRA)
No Banned Ingredients
Correct Leaflet & Labelling
MHRA Notification
E-Cigarettes
Nicotine Restrictions
Toxicological Risk Assessment (TRA)
No Banned Ingredients
Correct Leaflet & Labelling
MHRA Notification
Nicotine Content
Flavour Compounds (composition)
Toxicology of Compounds (eg diketones)
Batch Confirmation Checks (production)
Overall Health Effects
Health Effects of Nicotine
Safety of Eliquid Cartridges
Nicotine Vapour Risks (Heating Process)
Second-hand Exposure Risks
Risk of other potential toxins
Using Vaping to Quit Smoking
Benefits of Vaping compared to Smoking
E-cigarette Nicotine delivery
E-cigarette long term use in adults (Nicotine addiction)
Take-up by Young People
Nicotine Restrictions
Producers are required to restrict e-cigarette tanks to a capacity of no more than 2 ml.
The maximum volume of nicotine-containing e-liquid for sale in one refill container is restricted to 10 ml.
The nicotine strength of e-liquids is restricted to no more than 20 mg/ml.
Toxicological Risk Assessment (TRA)
Analytical testing and assessment of e-cigarette devices and liquids is necessary for product quality control.
Toxicological analysis of the chemicals in nicotine-containing liquid (eliquid) provides information that can be used to assess the potential risk for negative long-term health outcomes.
Chemical analysis of eliquid batches is used to confirm consistency in dosage formulations.
No Banned Ingredients
Eliquids used in e-cigarettes and refill containers must not contain any banned ingredients – including colourings, caffeine and taurine.
Correct Leaflet & Labelling
The LABEL on the product container must list ingredients where these are used in quantities of 0.1% or more of the final formulation of the Eliquid.
The ingredients must be listed in full in Notifications submitted to MHRA, ie the list should include all component chemicals.
The LEAFLET provided as a separate insert (or on the pack) must provide the user with information about safe use of the product, include appropriate advice on product storage and instructions to ensure there is no battery malfunction.
MHRA Notification
Producers of e-cigarettes are required to ensure Notification to MHRA has been submitted before an e-cigarette product is put on sale in the UK.
Product testing and analysis should be carried out and a Technical Dossier compiled for submission to MHRA.
The format and content of notifications are set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.
More information about submitting a notification is available on the UK Government (gov.uk) website.
Nicotine Content
Electronic cigarettes or e-cigarettes, produce an aerosol from a battery-powered, metal heating element and cartridge containing an e-liquid. The e-liquid (also known as ‘eLiquid’ and ‘Vape Juice’) will typically consist of humectants (propylene glycol [1,2-propanediol] and/or glycerin), flavorants, and Nicotine.
The eliquid can be tested and an analysed to find out how much Nicotine is present.
Flavour Compounds (composition)
Manufacturers add flavourings, for example, acetylpyrazine, which is a flavorant that can be described as giving a ‘nutty’ flavor/aroma to the e-cigarette when in use.
Some flavourings can be bad for our lungs and recent investigations have found that modified flavorings might be able to irritate lungs over the long term.
This is why producers are required to use analytical systems and parameters to determine the impurities in their eliquid products and determine how safe they are – before they go on the market.
Toxicology of Compounds (eg diketones)
Analytical systems are used for the qualitative determination of impurities found in the eliquid solutions used in e-cigarettes.
Solvents can mix and react with other ingredients in an eliquid, resulting in new chemicals that could potentially have harmful affect on health.
Scientists have discovered that cinnamon, vanilla, and cherry flavours react with propylene glycol, a main ingredient in many vape ‘juices’ (eliquids), creating entirely new chemicals.
Analysis of e-cigarette vapor has revealed the presence of compounds in addition to those found in eliquid analysis, ie the presence of formaldehyde, acetaldehyde, acrolein, and xylenes, as well as siloxanes.
It has been proven that exposure to diacetyl and related α-diketones causes respiratory-tract damage in humans and experimental animals.
Recent analysis and scientific studies underline the importance of testing of eliquids and vapour.
Batch Confirmation Checks (production)
Batch testing of the eliquid after manufacture provides comparison checks and allows for traceability.
Overall Health Effects
As e-cigarettes contain a non-tobacco, non-smoked nicotine product, the general view is that the risks associated with e-cigarettes are less than those linked to inhaling the smoke from burning tobacco.
They are presented as an alternative to smoking for those wanting to quit and a safer method of getting a controlled amount of nicotine into the body to satisfy the cravings of Nicotine addiction.
However, recent studies prove there are harmful affects on the health of people who are vaping, especially those using e-cigarettes over longer periods of time. There is concern about short term and long term harmful effects on the health of users and this extends to those who are exposed to the vapour around them, such as pregnant women, babies and children.
Health Effects of Nicotine
Nicotine is the addictive element in tobacco cigarettes AND e-cigarettes.
Nicotine has been proven to be a contributor to the development of cardiovascular disease and although not a carcinogen itself, may function in the body as a ‘tumour promoter’.
Nicotine may be involved in neuro-degeneration and aspects of the biology of malignant diseases.
Smoking tobacco cigarettes during pregnancy can have devastating consequences such as preterm deliveries and stillbirths. There are harmful effects on brain and lung development when women smoke during fetal development or during adolescence.
The growing evidence of the damage to your health caused by smoking is one of the main reasons for the development of safer e-cigarette products. The amount of nicotine in e-cigarettes is restricted to safe levels. Good Manufacturing Practices (GMP) are encouraged and e-cigarette manufacturers in the UK must ensure their products comply with the TPD requirements.
E-cigarettes and other vaping devices contain Nicotine and other chemical compounds which make them less harmful than smoking, but they are NOT completely risk-free.
The generally held view is that e-cigarette cartridges and the aerosol vapour that comes from heating eliquids cannot deliver toxic nicotine levels to the user.
Safety of Eliquid Cartridges
Eliquid cartridges are tested for safety and need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (RoHS).
The packaging and/or leaflet insert must include advice on safe use and product storage.
Nicotine Vapour Risks (Heating Process)
The most commonly used carrier fluids for nicotine in e-cigarette cartridges are propylene glycol (PG) and vegetable glycerine (VG).
Analysis of Nicotine and impurities in the aerosol vapour produced from heating e-cigarette solutions (eliquids) has revealed the presence of many compounds (in some cases more than 18) in addition to those found in the eliquid analysis.
These compounds found in Nicotine vapour have been shown to irritate people’s lungs. By vaping, there is a risk that these impurities provide a low-level stimulation of the ‘irritation receptors’ in the lungs leading to problems such as inflammation, chronic cough and asthma.
A study has shown that chronic exposure to PG indoors can induce or exacerbate conditions such as asthma and eczema in children.
Although VG is considered to be non-toxic, when heated to high temperatures it can produce acrolein, which is toxic.
There is evidence that e-cigarettes contain toxic substances, including small amounts of formaldehyde and acetaldehyde, which are carcinogenic.
As high voltage devices have been found to produce levels of formaldehyde similar to tobacco smoke, those devices designed to use lower voltage and producing much lower levels of this substance, could lead to safety improvements.
Ultimately, the risks to end users should not be played down, as they are being exposed to the e-cigarette vapour rather than the eliquid.
Second-hand Exposure Risks
Studies prove there are harmful effects on the health of people who are exposed to vaping by users in close proximity and especially in confined spaces.
To avoid second hand exposure risks, pregnant women, babies and children should avoid areas where people are using e-cigarettes and vaping products.
Risk of other potential toxins
The long-term health effects of aerosolising nicotine and other chemicals in e-cigarettes and other vaping devices is being studied and assessed. There is some evidence that the additives, heavy metals, ultrafine particles, and other ingredients they contain include toxins and carcinogens that are detrimental to health.
Manufacturers must test the products and achieve TPD compliance before they can offer them for sale in the UK.
As more information becomes available through testing and analysis, e-cigarette products should become safer for users and the risk of potential toxins should decrease.
Using Vaping to Quit Smoking
Although there is a continuing debate as to how effective it is, in the UK consumers are using e-cigarettes to help them to stop smoking tobacco products and/or to stop smoking completely.
‘Smokers who have tried other methods of quitting without success could be encouraged to try e-cigarettes (EC) to stop smoking and stop smoking services should support smokers using EC to quit by offering them behavioural support.’
‘E-cigarette (EC) users who were also ex-smokers, when asked why they were using EC gave their reasons and the top three were:
‘Impact of long term e-cigarette (EC) use on lung health:
ECs are unlikely to raise significant health concerns for the respiratory tract under normal condition of use’
Former smokers using and smokers intending to use ECs should receive correct information about residual risks and potential benefits’
Promoting further access to ECs may reduce risk and reverse harm’
Benefits of Vaping compared to Smoking
There is controversy surrounding safety claims and the perceived benefits of Vaping compared to Smoking. Scientists look at evidence of Acute vs. chronic effects on health, this needs to be reasonably specific and link to disease.
‘…the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco…’
‘There has been an overall shift towards the inaccurate perception of EC being as harmful as cigarettes […] in contrast to the current expert estimate that using EC is around 95% safer than smoking.’
Is this claim justified? Not quite, evidence suggests a more likely risk reduction of 60-80%.
‘Some smoking-related health effects are irreversible.’
‘Health outcomes confounded with past smoking behaviour of most EC users.’
‘95% risk reduction = 6.6 million fewer deaths’
‘60% risk reduction = 1.6 million fewer deaths’
We may never know exact level of harm reduction of e-cigarette use compared with smoking.
‘To assess the carcinogenic potential of different nicotine aerosols (e-cigarettes) scientists use data on tobacco smoke as a basis for comparing relative risk.
There are known carcinogens in tobacco (1,3-Butadiene, Acrylonitrile, Acetaldehyde, Acrylamide, Benzene). Analysis of tobacco products has produced a list of 93 chemical compounds, including:
75 carcinogens
25 respiratory toxicants
12 cardiovascular toxicants
There are toxicants found specifically in e-cigarettes (Formaldehyde, Acetaldehyde).’
‘… nicotine (NRT) alone causes acute endothelial dysfunction, although to a lesser extent than smoking a cigarette of the same nicotine yield.’
‘… coffee exerts an acute unfavourable effect on the endothelial function in healthy adults…’
‘There is a risk-continuum among harm reduction products, with e-cigarettes (new generation) emitting lower levels of toxins compared to THPs (Tobacco Heating Products)
The absolute difference in toxic emissions from tobacco cigarettes is much higher than the absolute difference between harm reduction products – smokers should make informed decisions’
‘Smoking abstinence by using e-cigarettes may improve respiratory function and symptoms’
‘No data about e-cigarettes use in smokers with pre-existing disease’
‘Very little is known about the health impact of long-term vaping’
‘Challenges: The large majority of EC users are smokers or ex-smokers . . . and research takes time’
Statistics from evidence gathered in the UK, shows that there has been a decline in tobacco smoking, and an increase in people making attempts to quit and being successful in quitting. This proves that consumers are finding out for themselves what the benefits are of vaping compared to smoking.
There are opportunities and challenges for analytical chemistry in supporting the continued development and use of safe and consistent dosage formulations as alternatives to tobacco products. Almost all scientific data on health risks associated with the use of e-cigarettes is coming from the manufacturers. More evidence is needed (particularly in terms of long-term effects) to determine the harm levels of Vaping and how this relates to the harm reduction compared to smoking.
E-cigarette Nicotine delivery
E-cigarettes (ECs) deliver a controlled amount of Nicotine as an aerosol vapour inhaled by the user. The amount of Nicotine taken into the lungs will vary depending on how the user is puffing on the EC and whether or not they are doing it in a confined space with or without other vapers or outside.
There is a trend for vapers that have been vaping for a longer period to go for ECs with more flavor and less nicotine.
‘When using the low-nicotine liquids, people generally feel a greater urge to vape.’
‘They overcompensated for the lower strength by puffing more frequently and for longer, and by increasing the power of their vaping devices when they were able to.’
‘The nicotine content of the liquid, the type of device used and the user’s puffing behaviour all influenced their nicotine exposure.’
‘Typically, e-cigarette users often choose lower-nicotine devices over time – but if they switch too soon, it may cause them to take compensatory measures like longer puffs or increasing the power of their device.’
‘If you’re trying to quit smoking and want to try e-cigarettes, it may be a good idea not to jump straight to low-nicotine products.’
‘A study measuring nicotine residue on surfaces in houses of smokers and vapers reported only negligible levels from vaping – 169 times lower than from smoking.’
E-cigarette long term use in adults (Nicotine addiction)
Nicotine is addictive. Most smokers use tobacco regularly because they are addicted to nicotine. Addiction is characterised by compulsive drug-seeking and use, even in the face of negative health consequences. The majority of smokers would like to stop smoking, and each year about half try to quit permanently. This is why smokers are being encouraged to change over to using e-cigarettes instead.
Long-term, the benefits of e-cigarette (EC) use outweighs the continuation of an addiction to a substance that does carry health risks.
‘Policy implications:
E-cigarette (EC) should not routinely be treated in the same way as smoking. It is not appropriate to prohibit EC use in health trusts and prisons as part of smoke free policies unless there is a strong rationale to do so.’
‘Key Messages:
Encouraging smokers who cannot or do not want to stop smoking to switch to EC could help reduce smoking related disease, death and health inequalities.
Take-up by Young People
There is no evidence that EC are undermining the long-term decline in cigarette smoking among adults and youth, and may in fact be contributing to it.
Despite some experimentation with EC among never smokers, EC are attracting very few people who have never smoked into regular EC use.
In terms of the ‘Normalisation Effect’ the study by ASH (2014b), found that most children using e-cigarettes had already smoked tobacco cigarettes.
The team at IFS Laboratories have the combined laboratory testing experience and highly specialised knowledge of Operational/Quality Management to help producers to manage their production. Tests are carried out in our fully equipped lab using the latest equipment. We are dedicated to delivering the highest quality of customer service, with a sense of warmth, friendliness, individual pride.
IFS Laboratories fully support the regulation of e-cigarettes. We have the expertise and testing capability to provide producers with the services they need to ensure their products meet the required government standards for quality and safety. Whatever the future of e-cigarettes is, the team at IFS share the same vision, to work with producers to improve the safety of their vaping products and minimise adverse side-effects.
IFS Laboratories is passionate about providing independent testing of electronic cigarettes to safeguard public health. Studies show that quitting smoking is one of the best things you can do for your health and properly regulated e-cigarettes can be used effectively as a life-saving strategy for smokers trying to quit. Healthcare experts think e–cigarettes could help eradicate smoking-related diseases.
Textile Innovation House
1 Lyons Road
Trafford Park
Manchester
M17 1RN
T: +44 (0) 161 50 50 650
E: info@ifs-labs.com
Testing for Textile Industries
Website: ifs-labs.com
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