In a move that defies logic and reason, legislators and anti-smoking groups all over the country are attempting to modify the definition of "smoking," in public smoking bans, to include electronic cigarettes.
Bills passed by New Jersey legislators (S-3053/S-3054), define electronic cigarettes the same as tobacco and prohibit use of the devices in indoor public places and workplaces, based largely on recent findings by the FDA.
"Electronic smoking devices have not been approved as to safety and efficacy by the federal Food and Drug Administration, and their use may pose a health risk to persons exposed to their smoke or vapor because of a known irritant contained therein and other substances that may, upon evaluation by that agency, be identified as potentially toxic to those inhaling the smoke or vapor," the bill's authors ascertained. (1)
In an email to the senators, the executive director of anti-tobacco group Smokefree Pennsylvania, William T. Godshall, urged the New Jersey lawmakers to vote down S-3053, while supporting proposed bill S-3054.
"To improve public health, Smokefree Pennsylvania urges you to SUPPORT [S-3054] (to ban sales of electronic cigarettes to minors under 19) and to REJECT [S-3053] (to ban adult use of electronic cigarettes in ALL indoor workplaces)," Godshall said.
............
See the link for all.
Saturday, December 12, 2009
This was compiled by my dear friend "Anon" the Vaping nun we all love so much!
Legal restrictions on PVs internationally.
Australia: Due to poisons legislation the sale of electronic cigarettes containing nicotine is illegal.
Austria: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. Nicotine cartridges need to be registered as medicinal products before they can be legally sold.
Belgium: Banned, but hardly enforced at all.
Brazil: Electronic cigarettes sales, importation or advertisement of any kind are forbidden. Anvisa, the Brazilian health and sanitation federal agency found the current health safety assessments about e-cigarettes to be unsatisfactory so the product is not eligible for commercial availability.
Canada: Compliance of electronic cigarette use with public smoking bans is currently under review. In March 2009, Health Canada called for the immediate cessation of imports, sales, and advertising of electronic smoking products containing nicotine and advised Canadians not to purchase or use any electronic smoking products. Under the Food and Drugs Act, electronic smoking products containing nicotine require market authorization before they can be imported, marketed or sold. No market authorization has been granted for any electronic smoking product.
Nuck says - "You cannot sell or import the liquid. The devices are fine so everyone splits orders. There are quite a few vendors openly selling and HC seems to be hands off for now anyway. It's pretty rare that an order gets stopped by customs but I think that has more to do with the load they are under rather than policy. Oddly enough, non-Canadians can freely import liquid."
http://www.hc-sc.gc.ca/dhp-mps/prodp..._e-cig-eng.php
Czech Republic: Electronic cigarette use and advertisement are currently unrestricted.
Denmark: Electronic cigarettes are legal, however nicotine cartridges are currently under a temporary ban while they undergo review by Danish health authorities.
Dubai (a state in the UAE): Banned - http://www.khaleejtimes.com/DisplayA...section=theuae
Europe: All electronic devices need to have CE mark approval.
Finland: Cartridges containing nicotine are illegal to sell or to purchase with intent to sell but are not illegal to purchase from overseas sources for personal use only.
Germany: No restrictions on possession and use; no restrictions known on sales. However, the legal situation has not yet been settled. Customs in some states of the Federal Republic of Germany deem e-cigs or nicotine-bearing liquid a medicinal product and do stop commercial or personal imports at the respective customs border (= EU outer border).
Hong Kong: Possession or sale of electronic cigarettes is illegal.
Iran: Possibly a ban there because of the ingredients in pvliquid.
Israel: Banned, both the import and sale of the product, including those that are marketed as nicotine-free - http://www.israelnationalnews.com/News/News.aspx/132629
Jordan: Banned - http://www.jordantimes.com/?news=13857
Korea: Allowed but to be taxed: http://www.koreatimes.co.kr/www/news...113_54218.html
Malaysia: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. They can be purchased over the counter at a pharmacy with proper prescription.
Mexico: Sale, production, distribution, importation or advertisement of any kind are forbidden, mainly because the design is too similar to a tobacco product.
Netherlands: Use of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.
New Zealand: The Ministry of Health has ruled that cartridges containing nicotine fall under the requirements of the Medicines Act and cannot be sold except as a registered medicine. New Zealanders are allowed to import device, cartridge and e-liquid (including nicotine) for personal use. This article suggests that NZ authorities are approving some PVs as medical devices - http://www.scoop.co.nz/stories/BU0906/S00521.htm
Singapore: Banned.
South Africa: Electronic cigarette use is currently unrestricted.
Tajikisan: Electronic cigarette use is currently unrestricted.
Thailand: Banned.
United Kingdom: Electronic cigarette use is currently unrestricted.
United States: The Food and Drug Administration (FDA) consider electronic cigarettes to be a drug delivery system under its jurisdiction. A number of import shipments of electronic cigarette products to the country have been seized. Legal action is underway to challenge FDA restrictions. There are also local laws that restrict the use of ecigs to smoking areas.
Uruguay: Banned - http://www.elpais.com.uy/091120/ultm...lo-electronico
Australia: Due to poisons legislation the sale of electronic cigarettes containing nicotine is illegal.
Austria: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. Nicotine cartridges need to be registered as medicinal products before they can be legally sold.
Belgium: Banned, but hardly enforced at all.
Brazil: Electronic cigarettes sales, importation or advertisement of any kind are forbidden. Anvisa, the Brazilian health and sanitation federal agency found the current health safety assessments about e-cigarettes to be unsatisfactory so the product is not eligible for commercial availability.
Canada: Compliance of electronic cigarette use with public smoking bans is currently under review. In March 2009, Health Canada called for the immediate cessation of imports, sales, and advertising of electronic smoking products containing nicotine and advised Canadians not to purchase or use any electronic smoking products. Under the Food and Drugs Act, electronic smoking products containing nicotine require market authorization before they can be imported, marketed or sold. No market authorization has been granted for any electronic smoking product.
Nuck says - "You cannot sell or import the liquid. The devices are fine so everyone splits orders. There are quite a few vendors openly selling and HC seems to be hands off for now anyway. It's pretty rare that an order gets stopped by customs but I think that has more to do with the load they are under rather than policy. Oddly enough, non-Canadians can freely import liquid."
http://www.hc-sc.gc.ca/dhp-mps/prodp..._e-cig-eng.php
Czech Republic: Electronic cigarette use and advertisement are currently unrestricted.
Denmark: Electronic cigarettes are legal, however nicotine cartridges are currently under a temporary ban while they undergo review by Danish health authorities.
Dubai (a state in the UAE): Banned - http://www.khaleejtimes.com/DisplayA...section=theuae
Europe: All electronic devices need to have CE mark approval.
Finland: Cartridges containing nicotine are illegal to sell or to purchase with intent to sell but are not illegal to purchase from overseas sources for personal use only.
Germany: No restrictions on possession and use; no restrictions known on sales. However, the legal situation has not yet been settled. Customs in some states of the Federal Republic of Germany deem e-cigs or nicotine-bearing liquid a medicinal product and do stop commercial or personal imports at the respective customs border (= EU outer border).
Hong Kong: Possession or sale of electronic cigarettes is illegal.
Iran: Possibly a ban there because of the ingredients in pvliquid.
Israel: Banned, both the import and sale of the product, including those that are marketed as nicotine-free - http://www.israelnationalnews.com/News/News.aspx/132629
Jordan: Banned - http://www.jordantimes.com/?news=13857
Korea: Allowed but to be taxed: http://www.koreatimes.co.kr/www/news...113_54218.html
Malaysia: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. They can be purchased over the counter at a pharmacy with proper prescription.
Mexico: Sale, production, distribution, importation or advertisement of any kind are forbidden, mainly because the design is too similar to a tobacco product.
Netherlands: Use of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.
New Zealand: The Ministry of Health has ruled that cartridges containing nicotine fall under the requirements of the Medicines Act and cannot be sold except as a registered medicine. New Zealanders are allowed to import device, cartridge and e-liquid (including nicotine) for personal use. This article suggests that NZ authorities are approving some PVs as medical devices - http://www.scoop.co.nz/stories/BU0906/S00521.htm
Singapore: Banned.
South Africa: Electronic cigarette use is currently unrestricted.
Tajikisan: Electronic cigarette use is currently unrestricted.
Thailand: Banned.
United Kingdom: Electronic cigarette use is currently unrestricted.
United States: The Food and Drug Administration (FDA) consider electronic cigarettes to be a drug delivery system under its jurisdiction. A number of import shipments of electronic cigarette products to the country have been seized. Legal action is underway to challenge FDA restrictions. There are also local laws that restrict the use of ecigs to smoking areas.
Uruguay: Banned - http://www.elpais.com.uy/091120/ultm...lo-electronico
"FDA smoke screen on e-cigarettes" (Washington Times)
By Dr. Elizabeth M. Whelan
At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?
The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.
In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.......
At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?
The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.
In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.......
Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313
Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313
Tobacco-specific nitrosamines in new tobacco
products
Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stephen S. Hecht
[Received 18 January 2005; accepted 7 July 2005]
New tobacco products, designed to attract consumers who are concerned about the health effects of tobacco, have
been appearing on the market. Objective evaluation of these products requires, as a first step, data on their
potentially toxic constituents. Tobacco-specific nitrosamines (TSNAs) are an important class of carcinogens in
tobacco products, but virtually no data were available on their levels in these products. In the present study, we
analyzed several new products—Ariva, Stonewall, Exalt, Revel, Smokey Mountain, and Quest—for TSNAs and
compared their TSNA levels with those in nicotine replacement products and conventional smokeless tobacco and
cigarette brands. TSNAs were not detected in Smokey Mountain, which is a tobacco-free snuff product. The lowest
levels among the new products containing tobacco were in Ariva and Stonewall (0.26–0.28 mg/g wet weight of
product). The highest levels in the new products were found in Exalt (3.3 mg/g tobacco), whereas Revel and Quest
had intermediate amounts. Only trace amounts were found in nicotine replacement products, and conventional
brands had levels consistent with those reported in the literature. These results demonstrate that TSNA levels in
new tobacco products range from relatively low to comparable with those found in some conventional brands.
Introduction
Tobacco-specific nitrosamines (TSNAs) are widely
considered to be among the most important carcinogens
in smokeless tobacco products and cigarette
smoke (Bartsch & Spiegelhalder, 1996; Hecht, 1998;
Hecht & Hoffmann, 1988; Magee, 1996; Preston-
Martin & Correa, 1989). Two of these tobaccoalkaloid
derived compounds, 4-(methylnitrosamino)-
1-(3-pyridyl)-1-butanone (NNK) and N9-nitrosonornicotine
(NNN), are consistently carcinogenic in
laboratory animals, with NNK showing higher
activity (Hecht, 1998). The other two commonly
measured TSNAs are N9-nitrosoanabasine (NAB)
and N9-nitrosoanatabine (NAT). NAB is a weak
carcinogen and NAT apparently lacks activity (Hecht,
1998). NNK and NNN have recently been evaluated
by the International Agency for Research on Cancer
(2005) as carcinogenic to humans (Group 1).
In recent years, some new types of tobacco products
have been appearing on the market. Ariva is a lozenge
that contains compressed powdered tobacco and is
advertised as ‘‘the alternative for smokers in a smokefree
environment.’’ Stonewall Hard Snuff is another
compressed tobacco lozenge. Both products are made
with tobacco cured by a process that minimizes
nitrosamine formation. General and Exalt are types
of Swedish snus in which the GothiaTek process,
designed to ‘‘continuously reduce or eliminate alleged
harmful components in tobacco,’’ is used. Revel is an
American smokeless tobacco product designed for
‘‘tobacco satisfaction without smoking.’’ Smokey
Mountain is a tobacco-free and nicotine-free herbal
snuff, designed as a snuff substitute. Quest is a
cigarette available in three varieties: 1, low nicotine;
2, extra low nicotine; and 3, nicotine free. Quest
cigarettes are ‘‘the first that gradually step you to
nicotine free smoking.’’
With the exception of one review that includes
data for Ariva, Exalt, and Revel, but without
experimental details, we are aware of no published
studies on TSNA levels in these products (Rodu
& Jansson, 2004). These analyses were carried
out here, in parallel with analyses of TSNAs in
nicotine replacement products, and in conventional
ISSN 1462-2203 print/ISSN 1469-994X online # 2006 Society for Research on Nicotine and Tobacco
DOI: 10.1080/14622200500490151
Irina Stepanov, Ph.D., Stephen S. Hecht, Ph.D., The Cancer Center,
University of Minnesota, Minneapolis, MN; Joni Jensen, M.P.H.,
C.C.R.C., Dorothy Hatsukami, Ph.D., Transdisciplinary Tobacco Use
Research Center, University of Minnesota, Minneapolis, MN.
Correspondence: Stephen S. Hecht, Ph.D., The Cancer Center,
University of Minnesota, 420 Delaware Street SE – MMC 806,
Minneapolis, MN 55455, USA. Tel: +1 (612) 624-7604; Fax: +1 (612)
626-5135; E-mail: hecht002@umn.edu
Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313
smokeless tobacco products and cigarette tobacco,
for comparison.
Method
Tobacco samples
The 19 brands collected for analysis represent
smokeless spit-free tobacco products, compressed
tobacco lozenges, tobacco-free herbal snuff, new
cigarettes with reduced nicotine content, nicotine
replacement therapy products, and conventional
smokeless tobacco products and cigarettes. The
products were purchased between June 2003 and
January 2005. General was ordered online from Snus
Worldwide, Sweden. Exalt was purchased from retail
stores in Washington, D.C., and Golden Valley,
Minnesota; it was also ordered online from Snus
Worldwide, Sweden (for comparison). Revel was
ordered online (houseoxford.com) and also purchased
in a convenience store in Fort Worth,
Texas. Ariva was also obtained from different
locations: A pharmacy in Belleville, Illinois; a
pharmacy in Richmond, Idaho; and a Virginia
cigarette factory outlet. Stonewall was purchased
from a tobacco shop in Minneapolis, Minnesota.
Quest cigarettes were ordered online through
smokes-spirits.com and 001Cigarettes.com; cigarettes
purchased in Richmond, Idaho, were analyzed
for comparison. Conventional moist snuff, tobaccofree
herbal snuff (Smokey Mountain), and commercial
premium cigarettes were obtained from retailers
in Minneapolis. Nicotine replacement therapy
products were purchased from a pharmacy in
Minneapolis. For 24 h prior to analysis, the tobacco
was conditioned at room temperature in a chamber
at a relative humidity of 60%.
Apparatus
Tobacco-specific nitrosamines were analyzed on a
model 5890 gas chromatograph (GC; Hewlett
Packard, Palo Alto, California) interfaced with a
model 610 thermal energy analyzer (TEA; Orion
Research, Beverly, Massachusetts). The gas chromatography
conditions were as follows: DB-1301
capillary column (30m60.32mm60.25 mm; 6%
[cyanopropylphenyl]methylpolysiloxane; J&W Scientific,
Folsom, California) and a 2m60.53mm deactivated
fused silica pre-column; flow rate 2.6 mL/min
He; splitless injection port temperature 225uC. The
following oven temperature program was used: 80uC
for 2 min, then 12uC/min to 150uC, then 7 min at
150uC, then 12uC/min to 200uC, then 10min at 200uC.
Reagents
Reference NNN, NNK, NAB, 5-methyl-N9-nitrosonornicotine
(5-McNNN), and 5-(methylnitrosamino)
-1-(3-pyridyl)-l-pentanone (C5-NNK) were synthesized
as described previously (Amin, Desai, Hecht, &
Hoffmann, 1996; Carmella, McIntee, Chen, & Hecht,
2000; Stepanov, Carmella, Hecht, & Duca, 2002).
NAT was purchased from Toronto Research
Chemicals Inc., Toronto, Ontario, Canada.
Tobacco-specific nitrosamine analyses
Moist snuff, cigarette tobacco, and lozenges. We used
a slight modification of a method described previously
(Adams, Brunnemann, & Hoffmann, 1983;
Stepanov, Hecht, Ramakrishnan, & Gupta, 2005).
Humidity-conditioned tobacco (200–500 mg) and
10mL of citrate-phosphate buffer (pH54.5) containing
ascorbic acid were added to a 30mL Nalgene
centrifuge tube (Nalge Nunc International,
Rochester, New York) to which 200 ng each of
5-MeNNN and C5-NNK internal standards
were added. The samples were homogenized for
30 s with a Polytron tissue homogenizer (Brinkmann
Instruments, Westbury, New York) and sonicated
for 1 hr. The buffer extracts were separated from the
particles of tobacco by high-speed centrifugation
(15,000 rpm, 10 min). The extracts were filtered into
50-mL glass screw-top centrifuge tubes (Kimble,
Vineland, New Jersey), and the pH was adjusted to 7
by adding 100 mL of 10N NaOH. Each sample was
applied to a 20-mL ChemElut cartridge (Varian,
Harbor City, California), eluted with 3620mL
CH2Cl2, and the eluants were combined and
concentrated to dryness with a model SVT200H
Speedvac concentrator (Thermo Savant,
Farmingdale, New York). Residues were dissolved
in 0.5mL of CH2Cl2 and further purified by solidphase
extraction using Sep-Pak Plus silica cartridges
(Waters Corp., Milford, Massachusetts), preequilibrated
with CH2Cl2. The cartridges were
washed with 5mL of CH2Cl2/ethyl acetate: 50/50,
and the TSNAs were eluted with 10mL of ethyl
acetate. The ethyl acetate eluants were concentrated
to dryness (Speedvac). The dry residues were
transferred into gas chromatography microvials with
3650 mL methanol, concentrated to dryness, and
redissolved in 100 mL of acetonitrile. Then 3 mL of the
prepared sample was injected into the GC-TEA.
Patch and gum. The patches were cut in three pieces
and, after removal of the backing, rolled into 30mL
Nalgene centrifuge tubes containing 10mL of citratephosphate
buffer (pH54.5). The gum was cut into
small pieces, added to Nalgene tubes containing
10mL of citrate phosphate buffer, and homogenized
for 30 s with a Polytron tissue homogenizer. Then
100 ng each of 5-MeNNN and C5-NNK internal
standards were added to the samples. The samples
were incubated overnight at 37uC and the next day
310 TOBACCO-SPECIFIC NITROSAMINES IN NEW TOBACCO PRODUCTS
were sonicated for 1 hr. The buffer extracts were
separated from the particles of patch or gum and
transferred into 50-mL glass screw-top centrifuge
tubes. The pH was adjusted to 7 by adding 100 mL of
10N NaOH, and each sample was extracted three
times with equal volumes of ethyl acetate. The
extracts were combined, dried with approximately
10 g of Na2SO4 and concentrated to dryness with a
Speedvac concentrator. Residues were dissolved in
0.5mL of CH2Cl2 and further purified by solid-phase
extraction and analyzed as described for tobacco
products.
Results
Table 1 summarizes levels of TSNAs in the products.
TSNAs were not detected in Smokey Mountain, a
tobacco-free snuff product. The lowest TSNA levels
among the new products that contain tobacco were
found in the compressed tobacco lozenges Ariva and
Stonewall, which had totals of 0.19 and 0.28 mg/g wet
weight of product, most of which was due to NAT.
The highest nitrosamine levels among the new
tobacco products were found in Exalt, and these
were independent of the place of purchase. TSNA
levels were relatively low in Quest cigarette tobacco,
as compared with Marlboro, Camel, Winston, and
Newport. The amounts of NNN were similar in
Quest 1, 2, and 3; the levels of the other TSNAs were
similar in Quest 1 and 2 and lower in the nicotine-free
Quest 3.
Nicotine replacement therapy products did not
contain detectable levels of NAT or NAB. Traces of
NNN were found in three out of six gum pieces taken
for analysis (0.002 mg/piece), and traces of NNK were
found in six patches analyzed (0.008 mg/patch). The
levels of TSNAs in the conventional products
represent means for two to six analyses, carried out
at different times.
We observed substantial variation in nitrosamine
content measured in the same brand at different
times (see Table 2 for some examples). The Swedish
snus General, produced in 2003, was found to
contain lower levels of TSNAs compared with that
produced in 2002. The tobacco of Marlboro and
Camel had variable levels of individual TSNAs, with
the total amount in Marlboro cigarettes generally
lower in 2004 than in 2001 (Table 2).
Discussion
Tobacco companies are trying to create alternative
smokeless tobacco products and safer cigarettes,
which would potentially reduce the risk of tobaccoattributable
cancers. A number of new brands are
being test marketed in the United States. These
products are targeted to smokers and smokeless
tobacco users who wish to reduce or quit tobacco use
or who want to use ‘‘safer’’ products. Manufacturers’
claims include statements of reduced toxin content
and implied reduced risk, but it may take years
before the real health effects of these new tobacco
products are known. TSNAs are among the most
important carcinogens in tobacco, and it is imperative
that objective data on levels of these compounds
be available.
The lowest TSNA levels in the tobacco-containing
products we analyzed were found in the compressed
tobacco lozenges Ariva and Stonewall. Levels of the
strongly carcinogenic NNN and NNK were only 56–
99 ng/g, with most of the TSNA content comprised of
NAT, which is apparently noncarcinogenic. These
products use Star Scientific specially cured tobacco
known to be low in TSNAs. The emergence of these
new products with relatively low levels of carcinogenic
TSNAs is an encouraging sign.
The Swedish snus General, which is manufactured
using the GothiaTek process and quality standard
designed to minimize nitrosamine contamination,
contained relatively low levels of TSNAs, compared
with conventional smokeless tobacco products. The
variation in TSNA content observed in General in
2002 and 2003 (Table 2) is consistent with a study by
the Swedish National Food Administration
(O¨ sterdahl, Jansson, & Paccou, 2004) that demonstrated
a noticeable decrease in TSNA content in
moist snuff on the Swedish market. However, TSNA
levels in Exalt, which is supposedly produced by the
same technology, were comparable with those in
some conventional commercial brands of smokeless
tobacco such as Copenhagen and Kodiak, which
have had relatively high amounts of these compounds
for many years (Hecht & Hoffman, 1988;
Hoffmann et al., 1995; Rodu et al., 2004). Lower
levels were found in Revel; however, these levels were
still considerably higher than nitrosamine levels in
other products such as food and beer (Bartsch &
Spiegelhalder, 1996). Based on comprehensive dietary
surveys, exposure to carcinogenic volatile nitrosamines
such as N-nitrosodimethylamine and Nnitrosopyrrolidine
is estimated to be about 1 mg/day
(Bartsch & Spiegelhalder, 1996). The same exposure
to carcinogenic TSNAs would be reached by using
just 1–2 g of Revel. One packet of Revel contains
approximately 27 g tobacco.
Quest cigarette tobacco contained substantial
amounts of NNN, which did not decrease with
reduced nicotine content. Levels of NNN and other
TSNAs in tobacco are a major determinant of smoke
levels (Fischer, Spiegelhalder, Eisenbarth, &
Preussmann, 1990). Therefore, cigarettes lacking
nicotine will still expose smokers to significant
amounts of known carcinogens. However, NNN
NICOTINE & TOBACCO RESEARCH 311
Table 1. Tobacco-specific nitrosamine levels.
Product
Tobacco-specific nitrosamine level (mg/g product wet weight)
NNN NNK NAT NAB Total
New tobacco products
Hard snuff
Ariva 0.019 0.037 0.12 0.008 0.19a
Stonewall 0.056 0.043 0.17 0.007 0.28b
Swedish snus
General 0.98 0.18 0.79 0.06 2.0c
Spit-free tobacco packets
Exalt
Purchased in Sweden 2.3 0.27 0.98 0.13 3.7d
Purchased in the United States 2.1 0.24 0.68 0.05 3.1b
Revel
Mint flavored 0.62 0.033 0.32 0.018 0.99b
Wintergreen flavored 0.64 0.032 0.31 0.017 1.0b
Tobacco-free snuff
Smokey Mountain nd nd nd nd ndb
Nicotine-reduced cigarettes
Quest 1 (low nicotine) 0.93 0.17 0.31 0.013 1.4d
Quest 2 (extra-low nicotine) 0.82 0.19 0.19 0.01 1.2d
Quest 3 (nicotine free) 0.83 0.054 0.045 0.003 0.93d
Nicotine replacement therapy products
NicoDerm CQ (patch, 4-mg nicotine)f nd 0.008 nd nd 0.008b
Nicorette (gum, 4-mg nicotine)f 0.002 nd nd nd 0.002b
Commit (lozenge, 2-mg nicotine)f nd nd nd nd ndb
Conventional tobacco products
Smokeless tobacco
Copenhagen
Snuff 2.2 0.75 1.8 0.12 4.8b
Long cut 3.9 1.6 1.9 0.13 7.5b
Skoal
Long cut straight 4.5 0.47 4.1 0.22 9.2b
Bandits 0.9 0.17 0.24 0.014 1.3b
Kodiak
Ice 2.0 0.29 0.72 0.063 3.1b
Wintergreen 2.2 0.41 1.8 0.15 4.5b
Cigarette tobacco
Marlboro
Full flavor 2.9 0.96 2.3 0.1 6.3e
Light 2.8 0.68 1.1 0.051 4.6b
Ultra-light 2.9 0.75 1.1 0.058 4.8b
Camel
Full flavor 2.5 0.90 1.7 0.091 5.2e
Light 2.7 0.55 1.3 0.061 4.6b
Ultra-light 2.8 0.77 1.2 0.055 4.8b
Winston (full flavor) 2.2 0.58 0.56 0.025 3.4b
Newport (full flavor) 1.1 0.83 1.9 0.055 3.9b
Note. NAB, N9-nitrosoanabasine; NAT, N9-nitrosoanatabine; nd, not detected; NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone;
NNN, N9-nitrosonornicotine. aMean of five analyses, each performed in duplicate. bSingle analysis performed in duplicate. cMean of two
analyses, each performed in duplicate. dMean of three analyses, each performed in duplicate. eMean of four analyses, each performed
in duplicate. fValues are expressed per piece.
Table 2. Variation of tobacco-specific nitrosamine levels in some products.
Product
Date of
purchase
Number of
samples
Tobacco-specific nitrosamine level (mg/g tobacco)
NNN NNK NAT NAB Total
General 2002 2 1.2 0.28 0.93 0.076 2.5
2003 2 0.78 0.075 0.65 0.049 1.6
Marlboro (full flavor) July 2001 2 4.3 1.8 2.7 0.14 8.9
Oct. 2003 2 3.0 1.2 4.9 0.19 9.3
Oct. 2004 2 2.0 0.37 0.71 0.03 3.1
Jan. 2005 2 2.5 0.49 1.0 0.046 4.0
Camel (full flavor) July 2001 2 3.1 1.4 1.6 0.11 6.2
Oct. 2003 2 1.9 1.2 2.8 0.15 6.1
Oct. 2004 2 2.1 0.40 0.75 0.032 3.3
Jan. 2005 2 3.0 0.56 1.5 0.074 5.2
Note. NAB, N9-nitrosoanabasine; NAT, N9-nitrosoanatabine; NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone; NNN, N9-nitrosonornicotine.
312 TOBACCO-SPECIFIC NITROSAMINES IN NEW TOBACCO PRODUCTS
and NNK levels in Quest were substantially lower
than in currently available conventional brands.
Overall, the results of the present study demonstrate
that TSNA levels in new tobacco products
range from relatively low to comparable with those
found in some conventional brands.
Acknowledgments
This study was supported by National Institutes of Health grants CA-
81301 and DA-13333.
References
Adams, J. D., Brunnemann, K. D., & Hoffmann, D. (1983). Rapid
method for the analysis of tobacco-specific N-nitrosamines by gasliquid
chromatography with a thermal energy analyzer. Journal of
Chromatography, 256, 347–351.
Amin, S., Desai, D., Hecht, S. S., & Hoffmann, D. (1996). Synthesis of
tobacco-specific N-nitrosamines and their metabolites and results of
related bioassays. Critical Reviews in Toxicology, 26, 139–147.
Bartsch, H., & Spiegelhalder, B. (1996). Environmental exposure to Nnitroso
compounds (NNOC) and precursors: An overview.
European Journal of Cancer Prevention, 5, 11–18.
Carmella, S. G., McIntee, E. J., Chen, M., & Hecht, S. S. (2000).
Enantiomeric composition of N9-nitrosonornicotine and N9-
nitrosoanatabine in tobacco. Carcinogenesis, 21, 839–843.
Fischer, S., Spiegelhalder, B., Eisenbarth, J., & Preussmann, R. (1990).
Investigations on the origin of tobacco-specific nitrosamines in
mainstream smoke of cigarettes. Carcinogenesis, 11, 723–730.
Hecht, S. S. (1998). Biochemistry, biology, and carcinogenicity of
tobacco-specific N-nitrosamines. Chemical Research in Toxicology,
11, 559–603.
Hecht, S. S., & Hoffmann, D. (1988). Tobacco-specific nitrosamines,
an important group of carcinogens in tobacco and tobacco smoke.
Carcinogenesis, 9, 875–884.
Hoffmann, D., Djordjevic, M. V., Fan, J., Zang, E., Glynn, T., &
Connolly, G. N. (1995). 5 leading U.S. commercial brands of moist
snuff in 1994—Assessment of carcinogenic N-nitrosamines. Journal
of the National Cancer Institute, 87, 1862–1869.
International Agency for Research on Cancer. (2006). Smokeless
tobacco and tobacco-specific nitrosamines. In, IARC Monographs
on the Evaluation of Carcinogenic Risks to Humans (Vol. 89). Lyon,
France: In press.
Magee, P. N. (1996). Nitrosamines and human cancer: Introduction
and overview. European Journal of Cancer Prevention, 5, 7–10.
O¨
sterdahl, B.-G., Jansson, C., & Paccou, A. (2004). Decreased levels of
tobacco-specific N-nitrosamines in moist snuff on the Swedish
market. Journal of Agricultural and Food Chemistry, 52, 5085–5088.
Preston-Martin, S., & Correa, P. (1989). Epidemiological evidence for
the role of nitroso compounds in human cancer. Cancer Surveys, 8,
459–473.
Rodu, B., & Jansson, C. (2004). Smokeless tobacco and oral cancer: A
review of the risks and determinants. Critical Reviews in Oral
Biology and Medicine, 15, 252–263.
Stepanov, I., Carmella, S. G., Hecht, S. S., & Duca, G. (2002). Analysis
of tobacco-specific nitrosamines in Moldovan cigarette tobacco.
Journal of Agricultural and Food Chemistry, 50, 2793–2797.
Stepanov, I., Hecht, S. S., Ramakrishnan, S., & Gupta, P. C. (2005).
Tobacco-specific nitrosamines in smokeless tobacco products
marketed in India. International Journal of Cancer, 116, 16–19.
NICOTINE & TOBACCO RESEARCH 313
Tobacco-specific nitrosamines in new tobacco
products
Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stephen S. Hecht
[Received 18 January 2005; accepted 7 July 2005]
New tobacco products, designed to attract consumers who are concerned about the health effects of tobacco, have
been appearing on the market. Objective evaluation of these products requires, as a first step, data on their
potentially toxic constituents. Tobacco-specific nitrosamines (TSNAs) are an important class of carcinogens in
tobacco products, but virtually no data were available on their levels in these products. In the present study, we
analyzed several new products—Ariva, Stonewall, Exalt, Revel, Smokey Mountain, and Quest—for TSNAs and
compared their TSNA levels with those in nicotine replacement products and conventional smokeless tobacco and
cigarette brands. TSNAs were not detected in Smokey Mountain, which is a tobacco-free snuff product. The lowest
levels among the new products containing tobacco were in Ariva and Stonewall (0.26–0.28 mg/g wet weight of
product). The highest levels in the new products were found in Exalt (3.3 mg/g tobacco), whereas Revel and Quest
had intermediate amounts. Only trace amounts were found in nicotine replacement products, and conventional
brands had levels consistent with those reported in the literature. These results demonstrate that TSNA levels in
new tobacco products range from relatively low to comparable with those found in some conventional brands.
Introduction
Tobacco-specific nitrosamines (TSNAs) are widely
considered to be among the most important carcinogens
in smokeless tobacco products and cigarette
smoke (Bartsch & Spiegelhalder, 1996; Hecht, 1998;
Hecht & Hoffmann, 1988; Magee, 1996; Preston-
Martin & Correa, 1989). Two of these tobaccoalkaloid
derived compounds, 4-(methylnitrosamino)-
1-(3-pyridyl)-1-butanone (NNK) and N9-nitrosonornicotine
(NNN), are consistently carcinogenic in
laboratory animals, with NNK showing higher
activity (Hecht, 1998). The other two commonly
measured TSNAs are N9-nitrosoanabasine (NAB)
and N9-nitrosoanatabine (NAT). NAB is a weak
carcinogen and NAT apparently lacks activity (Hecht,
1998). NNK and NNN have recently been evaluated
by the International Agency for Research on Cancer
(2005) as carcinogenic to humans (Group 1).
In recent years, some new types of tobacco products
have been appearing on the market. Ariva is a lozenge
that contains compressed powdered tobacco and is
advertised as ‘‘the alternative for smokers in a smokefree
environment.’’ Stonewall Hard Snuff is another
compressed tobacco lozenge. Both products are made
with tobacco cured by a process that minimizes
nitrosamine formation. General and Exalt are types
of Swedish snus in which the GothiaTek process,
designed to ‘‘continuously reduce or eliminate alleged
harmful components in tobacco,’’ is used. Revel is an
American smokeless tobacco product designed for
‘‘tobacco satisfaction without smoking.’’ Smokey
Mountain is a tobacco-free and nicotine-free herbal
snuff, designed as a snuff substitute. Quest is a
cigarette available in three varieties: 1, low nicotine;
2, extra low nicotine; and 3, nicotine free. Quest
cigarettes are ‘‘the first that gradually step you to
nicotine free smoking.’’
With the exception of one review that includes
data for Ariva, Exalt, and Revel, but without
experimental details, we are aware of no published
studies on TSNA levels in these products (Rodu
& Jansson, 2004). These analyses were carried
out here, in parallel with analyses of TSNAs in
nicotine replacement products, and in conventional
ISSN 1462-2203 print/ISSN 1469-994X online # 2006 Society for Research on Nicotine and Tobacco
DOI: 10.1080/14622200500490151
Irina Stepanov, Ph.D., Stephen S. Hecht, Ph.D., The Cancer Center,
University of Minnesota, Minneapolis, MN; Joni Jensen, M.P.H.,
C.C.R.C., Dorothy Hatsukami, Ph.D., Transdisciplinary Tobacco Use
Research Center, University of Minnesota, Minneapolis, MN.
Correspondence: Stephen S. Hecht, Ph.D., The Cancer Center,
University of Minnesota, 420 Delaware Street SE – MMC 806,
Minneapolis, MN 55455, USA. Tel: +1 (612) 624-7604; Fax: +1 (612)
626-5135; E-mail: hecht002@umn.edu
Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313
smokeless tobacco products and cigarette tobacco,
for comparison.
Method
Tobacco samples
The 19 brands collected for analysis represent
smokeless spit-free tobacco products, compressed
tobacco lozenges, tobacco-free herbal snuff, new
cigarettes with reduced nicotine content, nicotine
replacement therapy products, and conventional
smokeless tobacco products and cigarettes. The
products were purchased between June 2003 and
January 2005. General was ordered online from Snus
Worldwide, Sweden. Exalt was purchased from retail
stores in Washington, D.C., and Golden Valley,
Minnesota; it was also ordered online from Snus
Worldwide, Sweden (for comparison). Revel was
ordered online (houseoxford.com) and also purchased
in a convenience store in Fort Worth,
Texas. Ariva was also obtained from different
locations: A pharmacy in Belleville, Illinois; a
pharmacy in Richmond, Idaho; and a Virginia
cigarette factory outlet. Stonewall was purchased
from a tobacco shop in Minneapolis, Minnesota.
Quest cigarettes were ordered online through
smokes-spirits.com and 001Cigarettes.com; cigarettes
purchased in Richmond, Idaho, were analyzed
for comparison. Conventional moist snuff, tobaccofree
herbal snuff (Smokey Mountain), and commercial
premium cigarettes were obtained from retailers
in Minneapolis. Nicotine replacement therapy
products were purchased from a pharmacy in
Minneapolis. For 24 h prior to analysis, the tobacco
was conditioned at room temperature in a chamber
at a relative humidity of 60%.
Apparatus
Tobacco-specific nitrosamines were analyzed on a
model 5890 gas chromatograph (GC; Hewlett
Packard, Palo Alto, California) interfaced with a
model 610 thermal energy analyzer (TEA; Orion
Research, Beverly, Massachusetts). The gas chromatography
conditions were as follows: DB-1301
capillary column (30m60.32mm60.25 mm; 6%
[cyanopropylphenyl]methylpolysiloxane; J&W Scientific,
Folsom, California) and a 2m60.53mm deactivated
fused silica pre-column; flow rate 2.6 mL/min
He; splitless injection port temperature 225uC. The
following oven temperature program was used: 80uC
for 2 min, then 12uC/min to 150uC, then 7 min at
150uC, then 12uC/min to 200uC, then 10min at 200uC.
Reagents
Reference NNN, NNK, NAB, 5-methyl-N9-nitrosonornicotine
(5-McNNN), and 5-(methylnitrosamino)
-1-(3-pyridyl)-l-pentanone (C5-NNK) were synthesized
as described previously (Amin, Desai, Hecht, &
Hoffmann, 1996; Carmella, McIntee, Chen, & Hecht,
2000; Stepanov, Carmella, Hecht, & Duca, 2002).
NAT was purchased from Toronto Research
Chemicals Inc., Toronto, Ontario, Canada.
Tobacco-specific nitrosamine analyses
Moist snuff, cigarette tobacco, and lozenges. We used
a slight modification of a method described previously
(Adams, Brunnemann, & Hoffmann, 1983;
Stepanov, Hecht, Ramakrishnan, & Gupta, 2005).
Humidity-conditioned tobacco (200–500 mg) and
10mL of citrate-phosphate buffer (pH54.5) containing
ascorbic acid were added to a 30mL Nalgene
centrifuge tube (Nalge Nunc International,
Rochester, New York) to which 200 ng each of
5-MeNNN and C5-NNK internal standards
were added. The samples were homogenized for
30 s with a Polytron tissue homogenizer (Brinkmann
Instruments, Westbury, New York) and sonicated
for 1 hr. The buffer extracts were separated from the
particles of tobacco by high-speed centrifugation
(15,000 rpm, 10 min). The extracts were filtered into
50-mL glass screw-top centrifuge tubes (Kimble,
Vineland, New Jersey), and the pH was adjusted to 7
by adding 100 mL of 10N NaOH. Each sample was
applied to a 20-mL ChemElut cartridge (Varian,
Harbor City, California), eluted with 3620mL
CH2Cl2, and the eluants were combined and
concentrated to dryness with a model SVT200H
Speedvac concentrator (Thermo Savant,
Farmingdale, New York). Residues were dissolved
in 0.5mL of CH2Cl2 and further purified by solidphase
extraction using Sep-Pak Plus silica cartridges
(Waters Corp., Milford, Massachusetts), preequilibrated
with CH2Cl2. The cartridges were
washed with 5mL of CH2Cl2/ethyl acetate: 50/50,
and the TSNAs were eluted with 10mL of ethyl
acetate. The ethyl acetate eluants were concentrated
to dryness (Speedvac). The dry residues were
transferred into gas chromatography microvials with
3650 mL methanol, concentrated to dryness, and
redissolved in 100 mL of acetonitrile. Then 3 mL of the
prepared sample was injected into the GC-TEA.
Patch and gum. The patches were cut in three pieces
and, after removal of the backing, rolled into 30mL
Nalgene centrifuge tubes containing 10mL of citratephosphate
buffer (pH54.5). The gum was cut into
small pieces, added to Nalgene tubes containing
10mL of citrate phosphate buffer, and homogenized
for 30 s with a Polytron tissue homogenizer. Then
100 ng each of 5-MeNNN and C5-NNK internal
standards were added to the samples. The samples
were incubated overnight at 37uC and the next day
310 TOBACCO-SPECIFIC NITROSAMINES IN NEW TOBACCO PRODUCTS
were sonicated for 1 hr. The buffer extracts were
separated from the particles of patch or gum and
transferred into 50-mL glass screw-top centrifuge
tubes. The pH was adjusted to 7 by adding 100 mL of
10N NaOH, and each sample was extracted three
times with equal volumes of ethyl acetate. The
extracts were combined, dried with approximately
10 g of Na2SO4 and concentrated to dryness with a
Speedvac concentrator. Residues were dissolved in
0.5mL of CH2Cl2 and further purified by solid-phase
extraction and analyzed as described for tobacco
products.
Results
Table 1 summarizes levels of TSNAs in the products.
TSNAs were not detected in Smokey Mountain, a
tobacco-free snuff product. The lowest TSNA levels
among the new products that contain tobacco were
found in the compressed tobacco lozenges Ariva and
Stonewall, which had totals of 0.19 and 0.28 mg/g wet
weight of product, most of which was due to NAT.
The highest nitrosamine levels among the new
tobacco products were found in Exalt, and these
were independent of the place of purchase. TSNA
levels were relatively low in Quest cigarette tobacco,
as compared with Marlboro, Camel, Winston, and
Newport. The amounts of NNN were similar in
Quest 1, 2, and 3; the levels of the other TSNAs were
similar in Quest 1 and 2 and lower in the nicotine-free
Quest 3.
Nicotine replacement therapy products did not
contain detectable levels of NAT or NAB. Traces of
NNN were found in three out of six gum pieces taken
for analysis (0.002 mg/piece), and traces of NNK were
found in six patches analyzed (0.008 mg/patch). The
levels of TSNAs in the conventional products
represent means for two to six analyses, carried out
at different times.
We observed substantial variation in nitrosamine
content measured in the same brand at different
times (see Table 2 for some examples). The Swedish
snus General, produced in 2003, was found to
contain lower levels of TSNAs compared with that
produced in 2002. The tobacco of Marlboro and
Camel had variable levels of individual TSNAs, with
the total amount in Marlboro cigarettes generally
lower in 2004 than in 2001 (Table 2).
Discussion
Tobacco companies are trying to create alternative
smokeless tobacco products and safer cigarettes,
which would potentially reduce the risk of tobaccoattributable
cancers. A number of new brands are
being test marketed in the United States. These
products are targeted to smokers and smokeless
tobacco users who wish to reduce or quit tobacco use
or who want to use ‘‘safer’’ products. Manufacturers’
claims include statements of reduced toxin content
and implied reduced risk, but it may take years
before the real health effects of these new tobacco
products are known. TSNAs are among the most
important carcinogens in tobacco, and it is imperative
that objective data on levels of these compounds
be available.
The lowest TSNA levels in the tobacco-containing
products we analyzed were found in the compressed
tobacco lozenges Ariva and Stonewall. Levels of the
strongly carcinogenic NNN and NNK were only 56–
99 ng/g, with most of the TSNA content comprised of
NAT, which is apparently noncarcinogenic. These
products use Star Scientific specially cured tobacco
known to be low in TSNAs. The emergence of these
new products with relatively low levels of carcinogenic
TSNAs is an encouraging sign.
The Swedish snus General, which is manufactured
using the GothiaTek process and quality standard
designed to minimize nitrosamine contamination,
contained relatively low levels of TSNAs, compared
with conventional smokeless tobacco products. The
variation in TSNA content observed in General in
2002 and 2003 (Table 2) is consistent with a study by
the Swedish National Food Administration
(O¨ sterdahl, Jansson, & Paccou, 2004) that demonstrated
a noticeable decrease in TSNA content in
moist snuff on the Swedish market. However, TSNA
levels in Exalt, which is supposedly produced by the
same technology, were comparable with those in
some conventional commercial brands of smokeless
tobacco such as Copenhagen and Kodiak, which
have had relatively high amounts of these compounds
for many years (Hecht & Hoffman, 1988;
Hoffmann et al., 1995; Rodu et al., 2004). Lower
levels were found in Revel; however, these levels were
still considerably higher than nitrosamine levels in
other products such as food and beer (Bartsch &
Spiegelhalder, 1996). Based on comprehensive dietary
surveys, exposure to carcinogenic volatile nitrosamines
such as N-nitrosodimethylamine and Nnitrosopyrrolidine
is estimated to be about 1 mg/day
(Bartsch & Spiegelhalder, 1996). The same exposure
to carcinogenic TSNAs would be reached by using
just 1–2 g of Revel. One packet of Revel contains
approximately 27 g tobacco.
Quest cigarette tobacco contained substantial
amounts of NNN, which did not decrease with
reduced nicotine content. Levels of NNN and other
TSNAs in tobacco are a major determinant of smoke
levels (Fischer, Spiegelhalder, Eisenbarth, &
Preussmann, 1990). Therefore, cigarettes lacking
nicotine will still expose smokers to significant
amounts of known carcinogens. However, NNN
NICOTINE & TOBACCO RESEARCH 311
Table 1. Tobacco-specific nitrosamine levels.
Product
Tobacco-specific nitrosamine level (mg/g product wet weight)
NNN NNK NAT NAB Total
New tobacco products
Hard snuff
Ariva 0.019 0.037 0.12 0.008 0.19a
Stonewall 0.056 0.043 0.17 0.007 0.28b
Swedish snus
General 0.98 0.18 0.79 0.06 2.0c
Spit-free tobacco packets
Exalt
Purchased in Sweden 2.3 0.27 0.98 0.13 3.7d
Purchased in the United States 2.1 0.24 0.68 0.05 3.1b
Revel
Mint flavored 0.62 0.033 0.32 0.018 0.99b
Wintergreen flavored 0.64 0.032 0.31 0.017 1.0b
Tobacco-free snuff
Smokey Mountain nd nd nd nd ndb
Nicotine-reduced cigarettes
Quest 1 (low nicotine) 0.93 0.17 0.31 0.013 1.4d
Quest 2 (extra-low nicotine) 0.82 0.19 0.19 0.01 1.2d
Quest 3 (nicotine free) 0.83 0.054 0.045 0.003 0.93d
Nicotine replacement therapy products
NicoDerm CQ (patch, 4-mg nicotine)f nd 0.008 nd nd 0.008b
Nicorette (gum, 4-mg nicotine)f 0.002 nd nd nd 0.002b
Commit (lozenge, 2-mg nicotine)f nd nd nd nd ndb
Conventional tobacco products
Smokeless tobacco
Copenhagen
Snuff 2.2 0.75 1.8 0.12 4.8b
Long cut 3.9 1.6 1.9 0.13 7.5b
Skoal
Long cut straight 4.5 0.47 4.1 0.22 9.2b
Bandits 0.9 0.17 0.24 0.014 1.3b
Kodiak
Ice 2.0 0.29 0.72 0.063 3.1b
Wintergreen 2.2 0.41 1.8 0.15 4.5b
Cigarette tobacco
Marlboro
Full flavor 2.9 0.96 2.3 0.1 6.3e
Light 2.8 0.68 1.1 0.051 4.6b
Ultra-light 2.9 0.75 1.1 0.058 4.8b
Camel
Full flavor 2.5 0.90 1.7 0.091 5.2e
Light 2.7 0.55 1.3 0.061 4.6b
Ultra-light 2.8 0.77 1.2 0.055 4.8b
Winston (full flavor) 2.2 0.58 0.56 0.025 3.4b
Newport (full flavor) 1.1 0.83 1.9 0.055 3.9b
Note. NAB, N9-nitrosoanabasine; NAT, N9-nitrosoanatabine; nd, not detected; NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone;
NNN, N9-nitrosonornicotine. aMean of five analyses, each performed in duplicate. bSingle analysis performed in duplicate. cMean of two
analyses, each performed in duplicate. dMean of three analyses, each performed in duplicate. eMean of four analyses, each performed
in duplicate. fValues are expressed per piece.
Table 2. Variation of tobacco-specific nitrosamine levels in some products.
Product
Date of
purchase
Number of
samples
Tobacco-specific nitrosamine level (mg/g tobacco)
NNN NNK NAT NAB Total
General 2002 2 1.2 0.28 0.93 0.076 2.5
2003 2 0.78 0.075 0.65 0.049 1.6
Marlboro (full flavor) July 2001 2 4.3 1.8 2.7 0.14 8.9
Oct. 2003 2 3.0 1.2 4.9 0.19 9.3
Oct. 2004 2 2.0 0.37 0.71 0.03 3.1
Jan. 2005 2 2.5 0.49 1.0 0.046 4.0
Camel (full flavor) July 2001 2 3.1 1.4 1.6 0.11 6.2
Oct. 2003 2 1.9 1.2 2.8 0.15 6.1
Oct. 2004 2 2.1 0.40 0.75 0.032 3.3
Jan. 2005 2 3.0 0.56 1.5 0.074 5.2
Note. NAB, N9-nitrosoanabasine; NAT, N9-nitrosoanatabine; NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone; NNN, N9-nitrosonornicotine.
312 TOBACCO-SPECIFIC NITROSAMINES IN NEW TOBACCO PRODUCTS
and NNK levels in Quest were substantially lower
than in currently available conventional brands.
Overall, the results of the present study demonstrate
that TSNA levels in new tobacco products
range from relatively low to comparable with those
found in some conventional brands.
Acknowledgments
This study was supported by National Institutes of Health grants CA-
81301 and DA-13333.
References
Adams, J. D., Brunnemann, K. D., & Hoffmann, D. (1983). Rapid
method for the analysis of tobacco-specific N-nitrosamines by gasliquid
chromatography with a thermal energy analyzer. Journal of
Chromatography, 256, 347–351.
Amin, S., Desai, D., Hecht, S. S., & Hoffmann, D. (1996). Synthesis of
tobacco-specific N-nitrosamines and their metabolites and results of
related bioassays. Critical Reviews in Toxicology, 26, 139–147.
Bartsch, H., & Spiegelhalder, B. (1996). Environmental exposure to Nnitroso
compounds (NNOC) and precursors: An overview.
European Journal of Cancer Prevention, 5, 11–18.
Carmella, S. G., McIntee, E. J., Chen, M., & Hecht, S. S. (2000).
Enantiomeric composition of N9-nitrosonornicotine and N9-
nitrosoanatabine in tobacco. Carcinogenesis, 21, 839–843.
Fischer, S., Spiegelhalder, B., Eisenbarth, J., & Preussmann, R. (1990).
Investigations on the origin of tobacco-specific nitrosamines in
mainstream smoke of cigarettes. Carcinogenesis, 11, 723–730.
Hecht, S. S. (1998). Biochemistry, biology, and carcinogenicity of
tobacco-specific N-nitrosamines. Chemical Research in Toxicology,
11, 559–603.
Hecht, S. S., & Hoffmann, D. (1988). Tobacco-specific nitrosamines,
an important group of carcinogens in tobacco and tobacco smoke.
Carcinogenesis, 9, 875–884.
Hoffmann, D., Djordjevic, M. V., Fan, J., Zang, E., Glynn, T., &
Connolly, G. N. (1995). 5 leading U.S. commercial brands of moist
snuff in 1994—Assessment of carcinogenic N-nitrosamines. Journal
of the National Cancer Institute, 87, 1862–1869.
International Agency for Research on Cancer. (2006). Smokeless
tobacco and tobacco-specific nitrosamines. In, IARC Monographs
on the Evaluation of Carcinogenic Risks to Humans (Vol. 89). Lyon,
France: In press.
Magee, P. N. (1996). Nitrosamines and human cancer: Introduction
and overview. European Journal of Cancer Prevention, 5, 7–10.
O¨
sterdahl, B.-G., Jansson, C., & Paccou, A. (2004). Decreased levels of
tobacco-specific N-nitrosamines in moist snuff on the Swedish
market. Journal of Agricultural and Food Chemistry, 52, 5085–5088.
Preston-Martin, S., & Correa, P. (1989). Epidemiological evidence for
the role of nitroso compounds in human cancer. Cancer Surveys, 8,
459–473.
Rodu, B., & Jansson, C. (2004). Smokeless tobacco and oral cancer: A
review of the risks and determinants. Critical Reviews in Oral
Biology and Medicine, 15, 252–263.
Stepanov, I., Carmella, S. G., Hecht, S. S., & Duca, G. (2002). Analysis
of tobacco-specific nitrosamines in Moldovan cigarette tobacco.
Journal of Agricultural and Food Chemistry, 50, 2793–2797.
Stepanov, I., Hecht, S. S., Ramakrishnan, S., & Gupta, P. C. (2005).
Tobacco-specific nitrosamines in smokeless tobacco products
marketed in India. International Journal of Cancer, 116, 16–19.
NICOTINE & TOBACCO RESEARCH 313
TSNA Report in Nicorette
**** OV/VM note for JRENAUD 10 May 1994 08 :18 Page 1 of 2
From: ASCHROTH--VCH0021A Date and time
To : JRENAUD --VCH0021A Jean-Marc Renaud
From : Andreas Schroth
25 .04 .94 15 :42 :12
To : .
Subject : Report : TSNA in "Nicorette" Chewing Gum ; vers . 2
Objective : To confirm the presence of TSNA
+
A sample of Nicorette chewing gum (2 units/15 pieces/pack, Kabi Pharmacia
AG, Sweden) was analysed for TSNA, applying the PM-Europe
standard procedure for the analysis of TSNA in tobacco filler [1] .
The nicotine content specified by the producer was 4 mg/gum . The
analysed quantity of chewing gum was chosen according to previous
experiments performed at PM-USA [2,3] .
Four pieces (4 g) were chopped and slurried with 250 ml of dichloromethane
. The extraction was performed over 24 h at ambient temperature
on a laboratory shaker at 170 rpm . The next day, the sample was well
dispensed . The extract appeared as a white suspension of insoluble
material, yielding a milky, colorless to slightly yellowish supernatant
upon precipitation . The suspension was filtered, evaporated to a final
volume of ca . 3 ml and chromatographed as described in the reference
procedure [1] . The fraction obtained after chromatography produced a
white precipitate upon evaporation to a final volume of approx . 3 ml .
The sticky, viscous liquid residue, obviously still being saturated with
large amounts of high molecular weight material, was filtered and
analysed by GC-TEA under standard conditions [1] . 3 ul were injected
per determination .
Consistency of the system performance during the analyses was monitored
by intermediate reinjection of the calibration solution and continuous
comparison of peakshapes and sensitivity .
For two reasons, analyses were started with a spiked sample : i) to
verify the suitability of the applied analytical conditions, and ii)
with regard to the expected low TSNA levels [2,3], to check and monitor
system performance for a real sample .
An extraction was performed as described above with a sample spiked at
the 0 .1 ppm level (table 1), followed by three extractions of untreated
material . After two injections, a significant degradation of system performance
was noted . Background noise increased by 100%, and a 50% decrease
in sensitivity was observed . Heating of the column for 1 h at
the end of each analysis did not improve the chromatograms . Consequently,
detection limits derived from early injections of spiked samples
were not maintained but decreased towards the end of the analyses .
The obtained results for fortified and real samples are listed below .
Table 1 : Determination of TSNA in "Nicorette" Chewing Gum
Values represent ng TSNA per piece of chewing gum .
----------------------------
spiked found real samples [ng/piece]
[ng/piece] [ng/piece] 1 2 3
NNN 92 107 31 n .d . n .d . N[n
NAT 96 85 26 13 (*) 15 (*) 0F-•
NAB 107 63 14
N
E1J0N
GD
~
NNK 139 129 19 18 18 W
---------------------------------------------------------
(*) no separation from NAB ; NAB included in NAT value .
OV/VM note for JRENAUD 10 May 1994 08 :18 Page 2 of
n .d . not detected
With regard to the observed rapid degradation in system performance,
it must be emphasized that the values for the real samples, obtained
at the end of the analyses seri,es, may be close or inferior to the
detection limits derived at the beginning and can thus not be considered
in an absolute manner .
Inspection of the liner insert at the end of the analyses revealed
considerable amounts of condensed low volatile material in form of
droplets found even behind the glass wool packing . The continuous
increase of column contamination by this material might be a major
factor for the above reported degradation in system performance .
Moreover, the low TSNA content in the samples and the high viscosity
of the purified final extract did not allow further concentration
or increase of the injection volume .
Employment of megabore columns or columns with increased film thickness
and modification of the cleanup procedure could be considered
to obtain consistency in system performance and provide quantitative
results . The time allocated for the investigations, however, precluded
further efforts in this regard .
References
[1] Determination of tobacco-specific nitrosamines (TSNA) in tobacco
by thermal energy analyser (TEA)
PM-Europe laboratory procedure, compiled by JBE ; March 1993
[2] Determination of TSNA in Masterpiece Chewing Gum
Haut S .A ., PM-USA Inter-Office Memorandum to Kinser R .D . ; April 1987
[3] Determination of TSNA in Chewbacco Chewing Gum
Haut S .A., PM-USA Inter-Office Memorandum to Ellis C .K . ; May 1988
A . Schroth
Scientist Product Research
PHILIP MORRIS EUROPE R&D
CH-2003 Neuchatel
From: ASCHROTH--VCH0021A Date and time
To : JRENAUD --VCH0021A Jean-Marc Renaud
From : Andreas Schroth
25 .04 .94 15 :42 :12
To : .
Subject : Report : TSNA in "Nicorette" Chewing Gum ; vers . 2
Objective : To confirm the presence of TSNA
+
A sample of Nicorette chewing gum (2 units/15 pieces/pack, Kabi Pharmacia
AG, Sweden) was analysed for TSNA, applying the PM-Europe
standard procedure for the analysis of TSNA in tobacco filler [1] .
The nicotine content specified by the producer was 4 mg/gum . The
analysed quantity of chewing gum was chosen according to previous
experiments performed at PM-USA [2,3] .
Four pieces (4 g) were chopped and slurried with 250 ml of dichloromethane
. The extraction was performed over 24 h at ambient temperature
on a laboratory shaker at 170 rpm . The next day, the sample was well
dispensed . The extract appeared as a white suspension of insoluble
material, yielding a milky, colorless to slightly yellowish supernatant
upon precipitation . The suspension was filtered, evaporated to a final
volume of ca . 3 ml and chromatographed as described in the reference
procedure [1] . The fraction obtained after chromatography produced a
white precipitate upon evaporation to a final volume of approx . 3 ml .
The sticky, viscous liquid residue, obviously still being saturated with
large amounts of high molecular weight material, was filtered and
analysed by GC-TEA under standard conditions [1] . 3 ul were injected
per determination .
Consistency of the system performance during the analyses was monitored
by intermediate reinjection of the calibration solution and continuous
comparison of peakshapes and sensitivity .
For two reasons, analyses were started with a spiked sample : i) to
verify the suitability of the applied analytical conditions, and ii)
with regard to the expected low TSNA levels [2,3], to check and monitor
system performance for a real sample .
An extraction was performed as described above with a sample spiked at
the 0 .1 ppm level (table 1), followed by three extractions of untreated
material . After two injections, a significant degradation of system performance
was noted . Background noise increased by 100%, and a 50% decrease
in sensitivity was observed . Heating of the column for 1 h at
the end of each analysis did not improve the chromatograms . Consequently,
detection limits derived from early injections of spiked samples
were not maintained but decreased towards the end of the analyses .
The obtained results for fortified and real samples are listed below .
Table 1 : Determination of TSNA in "Nicorette" Chewing Gum
Values represent ng TSNA per piece of chewing gum .
----------------------------
spiked found real samples [ng/piece]
[ng/piece] [ng/piece] 1 2 3
NNN 92 107 31 n .d . n .d . N[n
NAT 96 85 26 13 (*) 15 (*) 0F-•
NAB 107 63 14
N
E1J0N
GD
~
NNK 139 129 19 18 18 W
---------------------------------------------------------
(*) no separation from NAB ; NAB included in NAT value .
OV/VM note for JRENAUD 10 May 1994 08 :18 Page 2 of
n .d . not detected
With regard to the observed rapid degradation in system performance,
it must be emphasized that the values for the real samples, obtained
at the end of the analyses seri,es, may be close or inferior to the
detection limits derived at the beginning and can thus not be considered
in an absolute manner .
Inspection of the liner insert at the end of the analyses revealed
considerable amounts of condensed low volatile material in form of
droplets found even behind the glass wool packing . The continuous
increase of column contamination by this material might be a major
factor for the above reported degradation in system performance .
Moreover, the low TSNA content in the samples and the high viscosity
of the purified final extract did not allow further concentration
or increase of the injection volume .
Employment of megabore columns or columns with increased film thickness
and modification of the cleanup procedure could be considered
to obtain consistency in system performance and provide quantitative
results . The time allocated for the investigations, however, precluded
further efforts in this regard .
References
[1] Determination of tobacco-specific nitrosamines (TSNA) in tobacco
by thermal energy analyser (TEA)
PM-Europe laboratory procedure, compiled by JBE ; March 1993
[2] Determination of TSNA in Masterpiece Chewing Gum
Haut S .A ., PM-USA Inter-Office Memorandum to Kinser R .D . ; April 1987
[3] Determination of TSNA in Chewbacco Chewing Gum
Haut S .A., PM-USA Inter-Office Memorandum to Ellis C .K . ; May 1988
A . Schroth
Scientist Product Research
PHILIP MORRIS EUROPE R&D
CH-2003 Neuchatel
tp189-c1-b
PUBLIC HEALTH STATEMENT
PROPYLENE GLYCOL
CAS#: 57-55-6
Division of Toxicology and Environmental Medicine September 1997
__________________________________________________________________________________________
DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service
Agency for Toxic Substances and Disease Registry
www.atsdr.cdc.gov/ Telephone: 1-800-232-4636 Fax: 770-488-4178 E-Mail: cdcinfo@cdc.gov
This Public Health Statement is the summary
chapter from the Toxicological Profile for
Propylene Glycol. It is one in a series of Public
Health Statements about hazardous substances and
their health effects. A shorter version, the
ToxFAQsTM is also available. This information is
important because this substance may harm you.
The effects of exposure to any hazardous substance
depend on the dose, the duration, how you are
exposed, personal traits and habits, and whether
other chemicals are present. For more information,
call the ATSDR Information Center at 1-800-232-
4636.
_____________________________________
This statement was prepared to give you
information about propylene glycol and to
emphasize the human health effects that may result
from exposure to it. The Environmental Protection
Agency (EPA) has identified 1,416 hazardous waste
sites as the most serious in the nation. These sites
make up the National Priorities List (NPL) and are
the sites targeted for long-term federal clean-up
activities. Propylene glycol has been identified in at
least 5 of the 1,416 NPL sites.
When a chemical is released from a large source,
such as an industrial plant, or from a container, such
as a drum or bottle, it enters the environment as a
chemical emission. This emission, which is also
called a release, does not always lead to exposure.
You can be exposed to a chemical only when you
come into contact with the chemical. You may be
exposed to it in the environment by breathing,
eating, or drinking substances containing the
chemical or from skin contact with it.
If you are exposed to a hazardous chemical such as
ethylene glycol, several factors will determine
whether harmful health effects will occur and what
the type and severity of those health effects will be.
These factors include the dose (how much), the
duration (how long), the route or pathway by which
you are exposed (breathing, eating, drinking, or skin
contact), the other chemicals to which you are
exposed, and your individual characteristics such as
age, sex, nutritional status, family traits, lifestyle,
and state of health.
1.1 WHAT IS PROPYLENE GLYCOL?
Propylene glycol is a synthetic liquid substance that
absorbs water. Propylene glycol is also used to
make polyester compounds, and as a base for deicing
solutions. Propylene glycol is used by the
chemical, food, and pharmaceutical industries as an
antifreeze when leakage might lead to contact with
food. The Food and Drug Administration (FDA)
has classified propylene glycol as an additive that is
“generally recognized as safe” for use in food. It is
used to absorb extra water and maintain moisture in
certain medicines, cosmetics, or food products. It is
a solvent for food colors and flavors, and in the
paint and plastics industries. Propylene glycol is
also used to create artificial smoke or fog used in
fire-fighting training and in theatrical productions.
Other names for propylene glycol are 1,2-dihydroxypropane,
1,2-propanediol, methyl glycol,
and trimethyl glycol.
Propylene glycol is clear, colorless, slightly syrupy
liquid at room temperature. It may exist in air in the vapor form, although propylene glycol must be heated or briskly shaken to produce a vapor.
Propylene glycol is practically odorless and
tasteless.
1.2 WHAT HAPPENS TO PROPYLENE
GLYCOL WHEN IT ENTERS THE
ENVIRONMENT
Waste streams from the manufacture of propylene
glycol are primarily responsible for the releases into
the air, water, and soil. Propylene glycol can enter
the environment when it is used as a runway and
aircraft de-icing agent. Propylene glycol can also
enter the environment through the disposal of
products that contains it. It is not likely to exist in
large amounts in the air. We have little information
about what happens to propylene glycol in the air.
The small amounts that may enter the air are likely
to break down quickly. If it escapes into the air, it
will take between 24 and 50 hours for half the
amount released to break down. Propylene glycol
can mix completely with water and can soak into
soil. It can break down relatively quickly (within
several days to a week) in surface water and in soil.
Propylene glycol can also travel from certain types
of food packages into the food in the package.
1.3 HOW MIGHT I BE EXPOSED TO
PROPYLENE GLYCOL?
Propylene glycol has been approved for use at
certain levels in food, cosmetics, and
pharmaceutical products. If you eat food products,
use cosmetics, or take medicines that contain it, you
will be exposed to propylene glycol, but these
amounts are not generally considered harmful.
People who work in industries that use propylene
glycol may be exposed by touching these products
or inhaling mists from spraying them. These
exposures tend to be at low levels, however.
Propylene glycol is used to make artificial smoke
and mists for fire safety training, theatrical
performances, and rock concerts. These artificial
smoke products may also be used by private
citizens. These products are frequently used in
enclosed spaces, where exposure may be more
intense.
1.4 HOW CAN PROPYLENE GLYCOL
ENTER AND LEAVE MY BODY?
Propylene glycol can enter your bloodstream if you
breathe air containing mists or vapors from this
compound. It can also enter your bloodstream
through your skin if you come in direct contact with
it and do not wash it off. If you eat products that
contain propylene glycol, it may enter your
bloodstream. Exposure of the general population to
propylene glycol is likely since many foods, drugs,
and cosmetics contain it.
Propylene glycol breaks down in the body in about
48 hours. However, studies of people and animals
show that if you have repeated eye, skin, nasal, or
oral exposures to propylene glycol for a short time,
you may develop some irritation.
1.5 HOW CAN PROPYLENE GLYCOL
AFFECT MY HEALTH?
Propylene glycol breaks down at the same rate as
ethylene glycol, although it does not form harmful
crystals when it breaks down. Frequent skin
exposure to propylene glycol can sometimes irritate
the skin.
1.6 ARE THERE MEDICAL TESTS TO
DETERMINE WHETHER I HAVE BEEN
EXPOSED TO PROPYLENE GLYCOL?
Propylene glycol is generally considered to be a
safe chemical, and is not routinely tested for, unless
specific exposure, such as to a medicine or
cosmetic, can be linked with the observed bad
symptoms. Since propylene glycol breaks down
very quickly in the body, it is very difficult to
detect.
1.7 WHAT RECOMMENDATIONS HAS
THE FEDERAL GOVERNMENT MADE
TO PROTECT HUMAN HEALTH?
The government has developed regulations and
guidelines for propylene glycol. These are designed
to protect the public from potential adverse health
effects.
The Food and Drug Administration (FDA) has
classified propylene glycol as “generally recognized
as safe,” which means that it is acceptable for use in
flavorings, drugs, and cosmetics, and as a direct
food additive. According to the World Health
Organization, the acceptable dietary intake of
propylene glycol is 25 mg of propylene glycol for
every kilogram (kg) of body weight.
1.8 WHERE CAN I GET MORE
INFORMATION?
If you have any more questions or concerns, please
contact your community or state health or
environmental quality department, or contact
ATSDR at the address and phone number below.
ATSDR can also tell you the location of
occupational and environmental health clinics.
These clinics specialize in recognizing, evaluating,
and treating illnesses that result from exposure to
hazardous substances.
Toxicological profiles are also available on-line at
www.atsdr.cdc.gov and on CD-ROM. You may
request a copy of the ATSDR ToxProfilesTM
CD-ROM by calling the toll-free information
and technical assistance number at 1-800-
CDCINFO (1-800-232-4636), by e mail at
cdcinfo@cdc.gov, or by writing to:
Agency for Toxic Substances and Disease Registry
Division of Toxicology and Environmental
Medicine
1600 Clifton Road NE
Mailstop F-32
Atlanta, GA 30333
Fax: 1-770-488-4178
Organizations for-profit may request copies of final
Toxicological Profiles from the following:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
Phone: 1-800-553-6847 or 1-703-605-6000
Web site: http://www.ntis.gov/
Reference
Agency for Toxic Substances and Disease Registry
(ATSDR). 1997. Toxicological profile for
propylene glycol. Atlanta, GA: U.S. Department of
Health and Human Services, Public Health Service.
__________________________________________________________________________________________
DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service
Agency for Toxic Substances and Disease Registry
www.atsdr.cdc.gov/ Telephone: 1-800-232-4636 Fax: 770-488-4178 E-Mail: cdcinfo@cdc.gov
PROPYLENE GLYCOL
CAS#: 57-55-6
Division of Toxicology and Environmental Medicine September 1997
__________________________________________________________________________________________
DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service
Agency for Toxic Substances and Disease Registry
www.atsdr.cdc.gov/ Telephone: 1-800-232-4636 Fax: 770-488-4178 E-Mail: cdcinfo@cdc.gov
This Public Health Statement is the summary
chapter from the Toxicological Profile for
Propylene Glycol. It is one in a series of Public
Health Statements about hazardous substances and
their health effects. A shorter version, the
ToxFAQsTM is also available. This information is
important because this substance may harm you.
The effects of exposure to any hazardous substance
depend on the dose, the duration, how you are
exposed, personal traits and habits, and whether
other chemicals are present. For more information,
call the ATSDR Information Center at 1-800-232-
4636.
_____________________________________
This statement was prepared to give you
information about propylene glycol and to
emphasize the human health effects that may result
from exposure to it. The Environmental Protection
Agency (EPA) has identified 1,416 hazardous waste
sites as the most serious in the nation. These sites
make up the National Priorities List (NPL) and are
the sites targeted for long-term federal clean-up
activities. Propylene glycol has been identified in at
least 5 of the 1,416 NPL sites.
When a chemical is released from a large source,
such as an industrial plant, or from a container, such
as a drum or bottle, it enters the environment as a
chemical emission. This emission, which is also
called a release, does not always lead to exposure.
You can be exposed to a chemical only when you
come into contact with the chemical. You may be
exposed to it in the environment by breathing,
eating, or drinking substances containing the
chemical or from skin contact with it.
If you are exposed to a hazardous chemical such as
ethylene glycol, several factors will determine
whether harmful health effects will occur and what
the type and severity of those health effects will be.
These factors include the dose (how much), the
duration (how long), the route or pathway by which
you are exposed (breathing, eating, drinking, or skin
contact), the other chemicals to which you are
exposed, and your individual characteristics such as
age, sex, nutritional status, family traits, lifestyle,
and state of health.
1.1 WHAT IS PROPYLENE GLYCOL?
Propylene glycol is a synthetic liquid substance that
absorbs water. Propylene glycol is also used to
make polyester compounds, and as a base for deicing
solutions. Propylene glycol is used by the
chemical, food, and pharmaceutical industries as an
antifreeze when leakage might lead to contact with
food. The Food and Drug Administration (FDA)
has classified propylene glycol as an additive that is
“generally recognized as safe” for use in food. It is
used to absorb extra water and maintain moisture in
certain medicines, cosmetics, or food products. It is
a solvent for food colors and flavors, and in the
paint and plastics industries. Propylene glycol is
also used to create artificial smoke or fog used in
fire-fighting training and in theatrical productions.
Other names for propylene glycol are 1,2-dihydroxypropane,
1,2-propanediol, methyl glycol,
and trimethyl glycol.
Propylene glycol is clear, colorless, slightly syrupy
liquid at room temperature. It may exist in air in the vapor form, although propylene glycol must be heated or briskly shaken to produce a vapor.
Propylene glycol is practically odorless and
tasteless.
1.2 WHAT HAPPENS TO PROPYLENE
GLYCOL WHEN IT ENTERS THE
ENVIRONMENT
Waste streams from the manufacture of propylene
glycol are primarily responsible for the releases into
the air, water, and soil. Propylene glycol can enter
the environment when it is used as a runway and
aircraft de-icing agent. Propylene glycol can also
enter the environment through the disposal of
products that contains it. It is not likely to exist in
large amounts in the air. We have little information
about what happens to propylene glycol in the air.
The small amounts that may enter the air are likely
to break down quickly. If it escapes into the air, it
will take between 24 and 50 hours for half the
amount released to break down. Propylene glycol
can mix completely with water and can soak into
soil. It can break down relatively quickly (within
several days to a week) in surface water and in soil.
Propylene glycol can also travel from certain types
of food packages into the food in the package.
1.3 HOW MIGHT I BE EXPOSED TO
PROPYLENE GLYCOL?
Propylene glycol has been approved for use at
certain levels in food, cosmetics, and
pharmaceutical products. If you eat food products,
use cosmetics, or take medicines that contain it, you
will be exposed to propylene glycol, but these
amounts are not generally considered harmful.
People who work in industries that use propylene
glycol may be exposed by touching these products
or inhaling mists from spraying them. These
exposures tend to be at low levels, however.
Propylene glycol is used to make artificial smoke
and mists for fire safety training, theatrical
performances, and rock concerts. These artificial
smoke products may also be used by private
citizens. These products are frequently used in
enclosed spaces, where exposure may be more
intense.
1.4 HOW CAN PROPYLENE GLYCOL
ENTER AND LEAVE MY BODY?
Propylene glycol can enter your bloodstream if you
breathe air containing mists or vapors from this
compound. It can also enter your bloodstream
through your skin if you come in direct contact with
it and do not wash it off. If you eat products that
contain propylene glycol, it may enter your
bloodstream. Exposure of the general population to
propylene glycol is likely since many foods, drugs,
and cosmetics contain it.
Propylene glycol breaks down in the body in about
48 hours. However, studies of people and animals
show that if you have repeated eye, skin, nasal, or
oral exposures to propylene glycol for a short time,
you may develop some irritation.
1.5 HOW CAN PROPYLENE GLYCOL
AFFECT MY HEALTH?
Propylene glycol breaks down at the same rate as
ethylene glycol, although it does not form harmful
crystals when it breaks down. Frequent skin
exposure to propylene glycol can sometimes irritate
the skin.
1.6 ARE THERE MEDICAL TESTS TO
DETERMINE WHETHER I HAVE BEEN
EXPOSED TO PROPYLENE GLYCOL?
Propylene glycol is generally considered to be a
safe chemical, and is not routinely tested for, unless
specific exposure, such as to a medicine or
cosmetic, can be linked with the observed bad
symptoms. Since propylene glycol breaks down
very quickly in the body, it is very difficult to
detect.
1.7 WHAT RECOMMENDATIONS HAS
THE FEDERAL GOVERNMENT MADE
TO PROTECT HUMAN HEALTH?
The government has developed regulations and
guidelines for propylene glycol. These are designed
to protect the public from potential adverse health
effects.
The Food and Drug Administration (FDA) has
classified propylene glycol as “generally recognized
as safe,” which means that it is acceptable for use in
flavorings, drugs, and cosmetics, and as a direct
food additive. According to the World Health
Organization, the acceptable dietary intake of
propylene glycol is 25 mg of propylene glycol for
every kilogram (kg) of body weight.
1.8 WHERE CAN I GET MORE
INFORMATION?
If you have any more questions or concerns, please
contact your community or state health or
environmental quality department, or contact
ATSDR at the address and phone number below.
ATSDR can also tell you the location of
occupational and environmental health clinics.
These clinics specialize in recognizing, evaluating,
and treating illnesses that result from exposure to
hazardous substances.
Toxicological profiles are also available on-line at
www.atsdr.cdc.gov and on CD-ROM. You may
request a copy of the ATSDR ToxProfilesTM
CD-ROM by calling the toll-free information
and technical assistance number at 1-800-
CDCINFO (1-800-232-4636), by e mail at
cdcinfo@cdc.gov, or by writing to:
Agency for Toxic Substances and Disease Registry
Division of Toxicology and Environmental
Medicine
1600 Clifton Road NE
Mailstop F-32
Atlanta, GA 30333
Fax: 1-770-488-4178
Organizations for-profit may request copies of final
Toxicological Profiles from the following:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
Phone: 1-800-553-6847 or 1-703-605-6000
Web site: http://www.ntis.gov/
Reference
Agency for Toxic Substances and Disease Registry
(ATSDR). 1997. Toxicological profile for
propylene glycol. Atlanta, GA: U.S. Department of
Health and Human Services, Public Health Service.
__________________________________________________________________________________________
DEPARTMENT of HEALTH AND HUMAN SERVICES, Public Health Service
Agency for Toxic Substances and Disease Registry
www.atsdr.cdc.gov/ Telephone: 1-800-232-4636 Fax: 770-488-4178 E-Mail: cdcinfo@cdc.gov
ecigarettes_0709
Consumer Health Information
www.fda.gov/consumer
submitted to FDA, consumers currently have no way of knowing
· whether e-cigarettes are safe for their intended use
· about what types or concentrations of potentially harmful chemicals, or what dose of nicotine they are inhaling when they use these products
The potential health risks posed by the use of e-cigarettes were addressed in a July 22, 2009, phone conference between Joshua M. Sharfstein, M.D., principal deputy commissioner of food and drugs; Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium; Jonathan Samet, M.D., director of the University of Southern California’s Institute for Global Health; and Matthew T. McKenna, M.D., director of the Office on Smoking and Health at the national Centers for Disease Control and Prevention.
Conference participants stressed the importance of parents being aware of the health and marketing concerns associated with e-cigarettes. It was stated that parents may want to tell their children and teenagers that these products are not safe to use.
Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people.
In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.
During the phone conference, which was shared with the news media, FDA announced findings from a laboratory analysis that indicates that electronic cigarettes expose users to harmful chemical ingredients.
FDA’s Division of Pharmaceutical Analysis—part of the agency’s Center for Drug Evaluation and Research—analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarette samples.
One sample was found to contain diethylene glycol, a toxic chemical used in antifreeze. Several other samples were found to contain carcinogens, including nitrosamines.
Agency Actions
FDA has been examining and detaining shipments of e-cigarettes at the border and has found that the products it has examined thus far meet the definition of a combination drug device product under the Federal Food, Drug, and Cosmetic Act.
The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court.
FDA is planning additional activities to address its concerns about electronic cigarettes.
Meanwhile, health care professionals and consumers may report serious adverse events or product quality problems with the use of e-cigarettes to FDA through the MedWatch program, either online at www.fda.gov/Safety/MedWatch/default.htm or by phone at 1-800-FDA-1088.
This article appears on FDA’s Consumer Updates page (www.fda.gov/ForConsumers/ConsumerUpdates/default.htm), which features the latest on all FDA-regulated products.
For More Information
FDA Press Release
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
E-Cigarettes: FDA Web page
www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.
www.fda.gov/consumer
submitted to FDA, consumers currently have no way of knowing
· whether e-cigarettes are safe for their intended use
· about what types or concentrations of potentially harmful chemicals, or what dose of nicotine they are inhaling when they use these products
The potential health risks posed by the use of e-cigarettes were addressed in a July 22, 2009, phone conference between Joshua M. Sharfstein, M.D., principal deputy commissioner of food and drugs; Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium; Jonathan Samet, M.D., director of the University of Southern California’s Institute for Global Health; and Matthew T. McKenna, M.D., director of the Office on Smoking and Health at the national Centers for Disease Control and Prevention.
Conference participants stressed the importance of parents being aware of the health and marketing concerns associated with e-cigarettes. It was stated that parents may want to tell their children and teenagers that these products are not safe to use.
Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people.
In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.
During the phone conference, which was shared with the news media, FDA announced findings from a laboratory analysis that indicates that electronic cigarettes expose users to harmful chemical ingredients.
FDA’s Division of Pharmaceutical Analysis—part of the agency’s Center for Drug Evaluation and Research—analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarette samples.
One sample was found to contain diethylene glycol, a toxic chemical used in antifreeze. Several other samples were found to contain carcinogens, including nitrosamines.
Agency Actions
FDA has been examining and detaining shipments of e-cigarettes at the border and has found that the products it has examined thus far meet the definition of a combination drug device product under the Federal Food, Drug, and Cosmetic Act.
The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court.
FDA is planning additional activities to address its concerns about electronic cigarettes.
Meanwhile, health care professionals and consumers may report serious adverse events or product quality problems with the use of e-cigarettes to FDA through the MedWatch program, either online at www.fda.gov/Safety/MedWatch/default.htm or by phone at 1-800-FDA-1088.
This article appears on FDA’s Consumer Updates page (www.fda.gov/ForConsumers/ConsumerUpdates/default.htm), which features the latest on all FDA-regulated products.
For More Information
FDA Press Release
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
E-Cigarettes: FDA Web page
www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.
E-Cig related info- TREASURE TROVE
This is a list of other titles that you will want to look up....I will try to give links to as many as I can....
2008 NZ Ruyan Cartridge Report Oct 30
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
2008 Pillbox Toxicology Report
http://www.zigcigs.com/PDF/The-Electronic-Cigarette-Co-CHEM-Analysis.pdf
2008 Regulations on Electronic Products
http://www.ciwmb.ca.gov/electronics/Act2003/
2008 Sailebo ROHS Certification Certificate
2008 Regulations on Electronic Products
2008 Smoking Everywhere Press Release
2009 ALF Statement Against ECigs
ECOpureReport2009-04-14
http://www.prlog.org/cat-food/us/washington/
JCE_GCMS_Report
http://www.osun.org/Johnson+Creek-pdf.html
Nicotine Alkaloids in Food Plants
NJOY Response to FDA 7222009
http://www.njoythefreedom.com/contactcommerce/images/press_releases/NJOY%20Response%20to%20FDA%207222009.pdf
Roll Call 02 17 09 Congress Smokes Cigs
S.579 introduced in Senate
http://www.govtrack.us/congress/billtext.xpd?bill=s111-579
stepanov tsna in
http://www.e-cig.org/pdfs/TSNA-Study-in-Smokeless-Tobacco-Products.pdf
2008 NZ Ruyan Cartridge Report Oct 30
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
2008 Pillbox Toxicology Report
http://www.zigcigs.com/PDF/The-Electronic-Cigarette-Co-CHEM-Analysis.pdf
2008 Regulations on Electronic Products
http://www.ciwmb.ca.gov/electronics/Act2003/
2008 Sailebo ROHS Certification Certificate
2008 Regulations on Electronic Products
2008 Smoking Everywhere Press Release
2009 ALF Statement Against ECigs
ECOpureReport2009-04-14
http://www.prlog.org/cat-food/us/washington/
JCE_GCMS_Report
http://www.osun.org/Johnson+Creek-pdf.html
Nicotine Alkaloids in Food Plants
NJOY Response to FDA 7222009
http://www.njoythefreedom.com/contactcommerce/images/press_releases/NJOY%20Response%20to%20FDA%207222009.pdf
Roll Call 02 17 09 Congress Smokes Cigs
S.579 introduced in Senate
http://www.govtrack.us/congress/billtext.xpd?bill=s111-579
stepanov tsna in
http://www.e-cig.org/pdfs/TSNA-Study-in-Smokeless-Tobacco-Products.pdf
1997_ATF_Regulatory_Flexibility_Act
DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco and Firearms
27 CFR Part 275
[Notice No. 888]
RIN 1512-AC07
Implementation of Public Law 105-33, Section 9302, Requiring the
Qualification of Tobacco Products Importers
AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of
the Treasury.
ACTION: Notice of proposed rulemaking cross-referenced to temporary
regulations.......
Bureau of Alcohol, Tobacco and Firearms
27 CFR Part 275
[Notice No. 888]
RIN 1512-AC07
Implementation of Public Law 105-33, Section 9302, Requiring the
Qualification of Tobacco Products Importers
AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of
the Treasury.
ACTION: Notice of proposed rulemaking cross-referenced to temporary
regulations.......
Thursday, November 19, 2009
good resource and forum sites
Lets start off by listing off some good resource sites:
This work was done by the Vapers Forum folks, BIG thanks to ANON for making this possible, I will try to keep this updated as much s possible:
Vapers Forum: http://www.vapersforum.com/index.php
ASH UK: http://www.ash.org.uk/
A Brazilian forum: http://e-cig.forumbrasil.net/forum.htm
CASAA: http://www.casaa.org/
CASAA's forum: http://casaaforum.freeforums.org/index.php
DC's news site at his links page: http://www.e-cignews.com/
Dr Siegel's blog: http://tobaccoanalysis.blogspot.com/
A Dutch forum: http://www.e-roken.net/index.htm
ECA: http://www.ecassoc.org/
ECF: http://www.e-cigarette-forum.com/forum/
E Cigarette Direct (they have some good interviews and articles): http://www.ecigarettedirect.co.uk/ex.../articles.html
Dusty's E-Cig Review: http://www.e-cigreview.com/
Smokester's E-Cigs Academy: http://www.e-cigs.co.uk/
Ecigwars blog: http://www.ecigwars.com/
Emerald City Vapers: http://www.emeraldvapers.com/
French language sites -
Alain and Christian's magazine: http://ecig-mag.com/
Forum: http://ecigarette-public.superforum.fr/forum.htm
Forum: http://www.forum-ecigarette.com/
Harm Reduction Journal: http://www.harmreductionjournal.com/
Health NZ (this is where Ruyan research is published first): http://www.healthnz.co.nz/coynews.htm
Jane's forum: http://e-cigaretteforum.com/index.php
Lacey's blog (and shop) good place for US news: http://www.e-cig.org/
Long Island Vapers Club: http://www.vapersclub.com/
Moktarino's blog about treating ADHD with nicotine: http://vaporloper.blogspot.com/
Monte Alto's blog: http://smoke-vs-vapor.webs.com/
Nu-Vapor forum: http://www.nu-vapor.com/forum/
Right to Vape: http://www.righttovape.com/index.php
A Spanish language forum: http://www.vapeando.com/foro/
Texas Vapers Club: http://tejasvapin.com/
Tobacco Harm Reduction: http://www.tobaccoharmreduction.org/faq/ecigs.htm
Trog's Screwdriver forum: http://www.ecigscrewdriver.com/
Vapeatron: http://www.vapeatron.com/
Social network site VapersPlace: http://www.vapersplace.com/
Vapers World forum: http://ecigworld.proboards.com/index.cgi
VaporCast podcasts: http://vaporcast.com/
A US forum - Vapor Talk: http://www.vaportalk.com
Vick's blog: http://personalvapes.blogspot.com/
Xsmoker Andy's smoking alternatives site: http://xsmoker.info/?q=node/1
This work was done by the Vapers Forum folks, BIG thanks to ANON for making this possible, I will try to keep this updated as much s possible:
Vapers Forum: http://www.vapersforum.com/index.php
ASH UK: http://www.ash.org.uk/
A Brazilian forum: http://e-cig.forumbrasil.net/forum.htm
CASAA: http://www.casaa.org/
CASAA's forum: http://casaaforum.freeforums.org/index.php
DC's news site at his links page: http://www.e-cignews.com/
Dr Siegel's blog: http://tobaccoanalysis.blogspot.com/
A Dutch forum: http://www.e-roken.net/index.htm
ECA: http://www.ecassoc.org/
ECF: http://www.e-cigarette-forum.com/forum/
E Cigarette Direct (they have some good interviews and articles): http://www.ecigarettedirect.co.uk/ex.../articles.html
Dusty's E-Cig Review: http://www.e-cigreview.com/
Smokester's E-Cigs Academy: http://www.e-cigs.co.uk/
Ecigwars blog: http://www.ecigwars.com/
Emerald City Vapers: http://www.emeraldvapers.com/
French language sites -
Alain and Christian's magazine: http://ecig-mag.com/
Forum: http://ecigarette-public.superforum.fr/forum.htm
Forum: http://www.forum-ecigarette.com/
Harm Reduction Journal: http://www.harmreductionjournal.com/
Health NZ (this is where Ruyan research is published first): http://www.healthnz.co.nz/coynews.htm
Jane's forum: http://e-cigaretteforum.com/index.php
Lacey's blog (and shop) good place for US news: http://www.e-cig.org/
Long Island Vapers Club: http://www.vapersclub.com/
Moktarino's blog about treating ADHD with nicotine: http://vaporloper.blogspot.com/
Monte Alto's blog: http://smoke-vs-vapor.webs.com/
Nu-Vapor forum: http://www.nu-vapor.com/forum/
Right to Vape: http://www.righttovape.com/index.php
A Spanish language forum: http://www.vapeando.com/foro/
Texas Vapers Club: http://tejasvapin.com/
Tobacco Harm Reduction: http://www.tobaccoharmreduction.org/faq/ecigs.htm
Trog's Screwdriver forum: http://www.ecigscrewdriver.com/
Vapeatron: http://www.vapeatron.com/
Social network site VapersPlace: http://www.vapersplace.com/
Vapers World forum: http://ecigworld.proboards.com/index.cgi
VaporCast podcasts: http://vaporcast.com/
A US forum - Vapor Talk: http://www.vaportalk.com
Vick's blog: http://personalvapes.blogspot.com/
Xsmoker Andy's smoking alternatives site: http://xsmoker.info/?q=node/1
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