Evaluation of e-cigarettes

Subject: Evaluation of e-cigarettes Background: The Center for Drug Evaluation and Research through the Office of Compliance (OC) has requested that the Division of Pharmaceutical Analysis (DPA) evaluate two brands of electronic cigarettes (e-cigarettes) for nicotine content and other impurities. An e-cigarette is advertised as an alternative to smoked tobacco products. It is a battery-powered device that provides inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine mixture as shown in Figure 1. The Center is concerned that in addition to nicotine delivery, the vapor may also provide other potentially harmful volatile components. DPA was asked to quantitate

the amount of nicotine present in each brand and to evaluate each brand for the presence of tobacco specific nitrosamines (TSNA), certain tobacco specific impurities, ethylene glycol (EG) and diethylene glycol (DEG).

Test Products: Njoy e-cigarette (Reference 1) with various cartridges Smoking Everywhere Electronic Cigarette (Reference 2) with various cartridges Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods Conclusions: Nicotine is present in both products. The Smoking Everywhere Electronic Cigarette cartridges listed as containing no nicotine in some cases had very low amounts of nicotine present. Tobacco specific nitrosamines and tobacco specific impurities were detected in both products at very low levels. DEG was identified in one cartridge, Smoking Everywhere 555 High.

See Table 1 for results of analyses of entire cartridges after extraction. A sparging apparatus (see figure in Attachment A) and headspace GC (HS-GC) analysis were utilized to simulate actual use of these products. With the sparging apparatus, nicotine was detected in cartridges claiming to contain nicotine and quantitated by LC-UV; cotinine was also found in some products by this procedure. Repeat testing of 3 different cartridges with the same label (menthol high) gave varying results from 26.8 to 43.2 mcg nicotine/100 mL puff. HS-GC detected nicotine in both products and â-Nicotyrine was detected in all Njoy cartridges (see Table 2).

ScienceResearch

Vanillin

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers.

Vanilla is one of the most popular flavours worldwide. It comes from the fruit of the vanilla plant that contains beans or seeds from where the vanilla extracts are obtained. Vanillin is the main substance of the vanilla bean extract responsible for the characteristic sweet smelling flavour of vanilla.

Although vanillin can be extracted from vanilla plants, this is quite expensive. Therefore, artificial vanilla flavouring made up of synthetic vanillin or chemically modified ethylvanillin is produced for commercial use and has a stronger flavour.

General uses

As a vanilla flavour ingredient, vanillin has a wide range of uses within the food, drink, cosmetic, pharmaceutical, and fragrance industries.

Reported tobacco industry uses

Tobacco manufacturers use vanillin as a flavouring material in cigarettes. Vanillin (or other compounds that release vanillin) can be added to the tobacco, cigarette paper or filter.
Vanillin can make up to 0.05 % of the total weight of the tobacco used in one cigarette. Lower levels of ethylvanillin are added due to its stronger flavour.

Harmful health effects

Vanillin is generally regarded as safe for use in food and cosmetics. However, this does not suggest it is safe when inhaled from smoking cigarettes.Vanillin is known to release several substances when burnt. These include polycyclic aromatic hydrocarbons, which have been classed as human cancer causing agents by the International Agency for Research on Cancer (a leading expert cancer organisation).

Vanillin is also indirectly harmful as it masks the harshness of tobacco smoke, making smoking easier, which thereby encourages the smoking habit. This ultimately causes smokers to be exposed to higher levels of the toxic substances in cigarette smoke.

Vanilla is a popular flavour in many products and tobacco manufacturers use this fact to make the cigarette more desirable, especially to young or first time smokers. Non-smokers or bystanders may be more tolerant towards smokers who smoke cigarettes with a vanilla aroma because of its less
offensive and familiar smell.

Overall, by adding more desirable flavours such as vanillin to cigarettes tobacco manufacturers make it easier for smokers to become addicted.

Vanillin

Prune Juice Concentrate

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers.
Prunes are ripe plums that are dried. Concentrated prune juice is extracted from softened prunes. As a fruit extract, prune juice concentrate is very rich in sugars and is therefore naturally sweet.

General uses

Prune juice concentrate has many uses in the food industry, e.g. as a sweetener, colour and flavour enhancer, a binding agent in cereal bars, and also as a ‘humectant’ to help keep cakes and cookies moist.

Reported tobacco industry uses

Prune juice concentrate (along with other extracts from either the plum or prune) is reportedly used by tobacco manufacturers to add flavour to the tobacco at different stages of manufacturing. Prune juice concentrate can make up to about 0.5 % of the total weight of the tobacco used in one cigarette.

Harmful health effects

Prune juice concentrate, a fruit extract, is safe for use in food products. However, this does not suggest it is safe when inhaled from smoking cigarettes. Studies have yet to identify
the compounds produced from burning prune juice concentrate. However, the high sugar content of the concentrate suggests it is likely to behave in a similar way to sugar additives. This could lead to the formation of chemicals that are well known to cause cancer in humans such as polycyclic
aromatic hydrocarbons, and those thought to possibly cause cancer such as acetaldehyde. These compounds have been classified by the International Agency for Research on Cancer (a leading expert cancer organisation). Other toxic compounds that irritate the airways are also formed (e.g.
acrolein or 2-furfural).

The sugars also produce acidic compounds, which make it harder for the nicotine in the cigarette smoke to reach the brain. This forces smokers to inhale deeper and to also consume more cigarettes to get their nicotine fix. Furthermore, the use of prune juice concentrate may be indirectly harmful due to the formation of compounds called aldehydes (e.g. acetaldehyde), which can make cigarettes more addictive by enhancing the addictive potential of nicotine. Aldehydes are very reactive and produce compounds such as the substance harman, which can also enhance addictiveness due to
its mood-enhancing effect on the brain.

Prune juice concentrate is used to smoothen and mildly sweeten the smoke. It imparts a sweet taste making the smoke more palatable. The high sugar content of the concentrate provides caramel flavours when burnt that enhance the flavour and attractiveness of smoking. By adding prune juice
concentrate to improve the taste of the tobacco, the bitter taste of the smoke is sufficiently masked. Also, the sweet caramel flavours appeals to young people, which can make it easier for them to start smoking.

Prune juice concentrate may also be indirectly harmful by making smoking more pleasurable. This encourages the smoking habit, which could ultimately cause smokers to be exposed to higher levels of the toxic substances in cigarette smoke.

Overall, by adding more desirable flavours such as prune juice concentrate to cigarettes, tobacco manufacturers make it easier for smokers to become addicted.

Prune Juice Concentrate

Menthol

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers. Menthol is a natural compound found in several plants of the mint family e.g. the peppermint, cornmint, and spearmint herbs. When consumed it imparts a minty taste and smell, and has a characteristic cooling effect.

General uses

Menthol is also produced synthetically for commercial use, and is widely used in the food, flavour, oral hygiene, cosmetic, and pharmaceutical industries. The tobacco industry is one of the main users of menthol.

Reported tobacco industry uses

Menthol is one of the most commonly used additives in the tobacco industry. It has been used in tobacco products since the 1920s to suppress the harshness of smoke and as a smoothing alternative for smokers suffering from colds. Menthol is the only type of tobacco additive that is sold as a particular type of cigarette i.e. ‘Menthol cigarettes’. Menthol is added to cigarettes to provide a distinctive (brand-specific) mint flavour to the inhaled smoke. The menthol is added to several parts
of the cigarette: either directly to the tobacco, the inner foil of the cigarette packet, the filter paper, or more recently as a crushable capsule inside the filter for a stronger effect. The amount of menthol added to the cigarette depends on whether it is being produced as a “menthol” cigarette.
Mentholated cigarettes contain menthol at levels that are up to 0.45 % of the total weight of the tobacco used in one cigarette (although levels up to 2 % are also reported). Non-mentholated
cigarettes can contain menthol at much lower levels that make up between 0.01 to 0.03 % of the total weight of tobacco.

Harmful health effects

Menthol is generally regarded as safe for use in food and cosmetics. However, this does not suggest it is safe when inhaled from smoking cigarettes. Although studies show that when a mentholated cigarette is burnt, almost all of the menthol is released into the smoke unchanged, a small
amount (0.5 %) does burn and can form compounds such as benzo[a]pyrene and benzene. These chemicals have been classed as human cancer-causing agents by the International Agency for Research on Cancer (a leading expert cancer organisation).

Menthol numbs the throat and increases the smoothness of the smoke, which masks the harsh effects of cigarette smoke and thereby makes it easier to smoke. Menthol cigarette smokers also tend to inhale more deeply for the cooling effect. These effects (together with the minty taste) particularly
appeals to young people as studies have shown that menthol cigarettes are commonly used in adolescents and is often their first cigarette brand of choice.

Tobacco manufacturers recognise that the cooling effect of menthol makes for a pleasurable smoking experience and, therefore, also add menthol to the tobacco used in nonmenthol
(i.e. regular) cigarettes. This provides a smoother and less harsh smoke without the mint taste. Other tobacco additives used for this purpose include peppermint, spearmint, thyme and eucalyptus oils, and the chemical methyl salicylate. Consequently, by adding menthol, tobacco manufacturers
increase the attractiveness and appeal of cigarettes.

The sensory experience from smoking menthol cigarettes can make it difficult to stop as the pleasurable taste, odour, and cooling effects may reinforce the smoking habit. Indeed,
menthol’s numbing effects on the lungs may allow many smokers to inhale more deeply to get their nicotine fix. Menthol’s use in medicinal products can also give smokers a false sense of safety. Studies have shown that menthol cigarette smokers often have the wrong impression that
the compound offers them some sort of health protection compared to non-menthol cigarettes. This can encourage continued consumption and helps sustain the smoking habit and thus greater exposure to the toxic substances in cigarette smoke.


Menthol an Additive

Liquorice Extract

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers. Liquorice (or licorice) is the root of the liquorice plant from which the characteristically sweet liquorice flavour
is extracted. The extract contains the very sweet substance glycyrhizzin, as well as sugars.

General uses

The root or the extract is used as a source of liquorice flavour. The liquor from the extract is often processed into a powder or a more concentrated solid block. The liquorice root/extract is widely used in the food industry as a sweetening agent, or flavouring ingredient in drinks, candy and gum. Due to its medicinal properties it is also used in both traditional and herbal medicines e.g. in the
pharmaceutical industry liquorice is used in over-thecounter drugs and cough syrups.

Reported tobacco industry uses

Tobacco manufacturers reportedly use liquorice at different stages of manufacturing to add flavour to the tobacco and to sweeten the smoke. Liquorice gives a mellow, sweet and woody note to the smoke.
The amount of liquorice added to the cigarette can make up to 4 % of the total weight of the tobacco used in one cigarette. Liquorice is also used as a flavour for other tobacco products such as cigars, and chewing tobacco.

Harmful health effects

Liquorice is generally regarded as safe for use in food and cosmetics. However, this does not suggest it is safe when inhaled from smoking cigarettes. When liquorice extracts are burnt they produce several toxic compounds including some that are well known to cause cancer in humans (e.g.
benzene), or those that could possibly cause cancer (e.g. acetaldehyde). Other toxic substances produced include the chemicals toluene and phenol that could cause other damaging
health effects.

The sugars in the extract can also produce acidic compounds, which make it harder for the nicotine in the cigarette smoketo reach the brain. This forces smokers to inhale deeper and to also consume more cigarettes to get their nicotine fix. Furthermore, the use of liquorice may be indirectly harmful
due to the formation of compounds called aldehydes (e.g. acetaldehyde), which can make cigarettes more addictive by enhancing the addictive potential of nicotine. Aldehydes are very reactive and produce other compounds such as the substance harman, which can also make cigarettes more
addictive due to its mood-enhancing effect on the brain.

The addition of liquorice extract makes the smoking experience more pleasurable in several ways, i.e. it helps the tobacco to stay moist, balances the overall flavour of the cigarette, and reduces dryness in the mouth and throat. Furthermore, the caramel flavours produced when the sugars in the liquorice extract are burnt help enhance the flavour and attractiveness of smoking. Also, the glycyrhizzin
that is present could potentially to open up the airways, and in combination with other ingredients could allow smokers to inhale deeper, making it easier for them to get their nicotine fix.

Therefore, by adding more desirable flavours such as liquorice to cigarettes, tobacco manufacturers succeed in making smoking more pleasurable. This not only encourages the smoking habit, but also makes it easier for smokers to become addicted, which ultimately causes them to be exposed to higher levels of the toxic substances in cigarette smoke.

Liquorice Extract

Carob Bean Extract and Gum

Carob Bean Extract and Gum

Additives are substances intentionally added to tobacco
products by tobacco industry in order to render toxic tobacco
products palatable and acceptable to consumers.
Carob, which is also referred to as the carob pod or carob
bean, is the fruit of the evergreen carob tree. Each carob pod
contains seeds that sit in the pod’s pulp. The pulp is rich in
sugars and therefore is naturally sweet and tastes and looks
like chocolate. It can be ground into fine powder or used in
the form of an extract. The seeds also provide a source of
gum.

General uses

Carob bean extract and gum have many uses, especially in the
food and flavouring industry where it is used as a chocolate
or cocoa substitute, or as a thickener and food stabiliser. It is
also used in non-food industries such as the textile, cosmetic,
and pharmaceutical industry.
Reported tobacco industry uses
Carob bean extract and gum are used as a flavouring material
in commercial cigarettes. It imparts a sweet and nutty
taste that enriches the smoke flavour. The extract and gum
is applied to either the filter or the tobacco and makes up to
0.2 % of the total weight of the tobacco used in one cigarette.
Harmful health effects
Carob bean is generally regarded as safe for use in food
and cosmetics. However, this does not suggest it is safe
when inhaled from smoking cigarettes. Almost the entire
carob bean extract and gum that is added to the cigarette
is burnt while smoking. This results in the formation of
several harmful compounds, such as benzene. The sugars
that are present in the extract can produce compounds such
as polycyclic aromatic hydrocarbons, and formaldehyde.
These breakdown products of sugars have been classified as
human cancer-causing agents by the International Agency for
Research on Cancer (a leading expert cancer organisation).

The sugars also produce acidic compounds, which make it
harder for the nicotine in the cigarette smoke to reach the
brain. This forces smokers to inhale deeper, and consume
more cigarettes to get their nicotine fix. Furthermore, the use
of carob bean extract and gum may be indirectly harmful
due to the formation of compounds called aldehydes (e.g.
acetaldehyde), which can make cigarettes more addictive
by enhancing the addictive potential of nicotine. Aldehydes
are very reactive and produce other compounds such as the
substance harman, which can also make cigarettes more
addictive due to its mood-enhancing effect on the brain.

The addition of carob bean extract and gum to cigarettes
help mask the naturally harsh and irritating nature of tobacco
smoke by making it more pleasant and milder. In doing so,
this essentially silences the body’s natural cough response,
which would warn that the smoke is dangerous. The flavour
and attractiveness of smoking is also enhanced by the
caramel flavours that are produced when the sugars are
burnt.

Overall, by adding more desirable flavours such as carob
bean extract and gum to cigarettes, tobacco manufacturers
make it easier for smokers to become addicted. This can
ultimately lead to more cigarettes being smoked and thus
greater exposure to the toxic substances in cigarette smoke.

Carbob Bean Extract

Additives in tobacco products

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers.

The tobacco industry is made up of many companies that make and sell different types of tobacco products. Whether it is smoked, chewed, sniffed or inhaled second-hand, the use
of these tobacco products can and does cause debilitating and life-threatening diseases, as well as premature death.

The cigarette is the single most commonly used tobacco product
in the European Union (EU). Most people are aware that smoking cigarettes is harmful, as thousands of compounds are produced and released in the smoke, some of which
(hundreds) are toxic.

But what people may not be aware of is that most tobacco manufacturers add ingredients other
than tobacco to cigarettes that affect the chemical make-up of the smoke.

These ingredients are known as tobacco additives
and are reportedly used, for example, to:

■■give a cigarette a particular flavour;
■■control the way the cigarette burns;
■■keep the tobacco moist thus preventing it from drying out

To some people, the reasons for adding these substances to a consumer product may appear perfectly reasonable. They may argue that this is not necessarily a bad thing as it makes
for a better consumer experience. However, helping people to better tolerate and enjoy a product like cigarettes, which is well known to be toxic and carcinogenic, is an entirely different
issue and a matter of great concern.

Additives in tobacco products PDF