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

Guar Gum

Additives are substances intentionally added to tobacco products by tobacco industry in order to render toxic tobacco products palatable and acceptable to consumers.
Guar gum is an extract of the guar bean plant. It is taken from the seeds of the plant and due to its gelling properties is used commercially (in powdered form).

General uses

Guar gum has many uses particularly in the food, cosmetic and pharmaceutical industries where it is used as a thickener,binder, emulsifier and stabilizer. It is added to various foods
such as breakfast cereals, dairy products, gravy, processed vegetables, and baked goods.

Reported tobacco industry uses

The tobacco part of most cigarettes (i.e. the shredded brown interior) is a mixture of the tobacco leaf and a paper-likeproduct called ‘reconstituted tobacco’. Reconstituted tobacco is made up of mashed tobacco stems and other parts of the tobacco leaf that would otherwise be discarded. Tobacco
manufacturers reportedly add guar gum (and its derivatives) to help bind this reconstituted tobacco in cigarettes. Tobacco manufacturers also use guar gum to prepare the cigarette paper that wraps the tobacco.

The amount of guar gum added to bind the tobacco can make up between 0.6-1.8 % of the total weight of the tobacco used in one cigarette.

Harmful health effects

Guargum 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 a cigarette is burnt, the guar gum present produces several toxic compounds that are either well-known to cause cancer in humans (e.g.
formaldehyde, benzo[a]pyrene and benzene) or thought to possibly cause cancer in humans (e.g. acetaldehyde and styrene) as defined by the International Agency for Research on Cancer (a leading expert cancer organisation).

Furthermore, the use of guar 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.

Some of the compounds formed when guar gum is burnt have a distinctive flavour. For example, diacetyl is one of the substances produced and has a butterscotch flavour, which can make a cigarette more appealing due to the improved flavour of the smoke. 2-Furfural is also formed and has an
odour and taste that is described as sweet, woody, bready, and caramel-like. Therefore, these compounds help make a cigarette more attractive by imparting a pleasant flavour to the cigarette smoke. This can ultimately lead to more cigarettes being smoked and thus greater exposure harm due to the toxic substances in cigarette smoke.

 Guar Gum

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