The issue here goes to longevity of use. The Clinical Data on the baseline product that was used---that being Nicotrol is straight forward and very well spelled out:
[FONT=Arial,Bold]WARNINGS
[/FONT]Nicotine from any source can be toxic and addictive... the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement
[FONT=Arial,Bold]PRECAUTIONS
[/FONT]
Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged. The clinical findings is not for extended use of the product beyond six months .
It can be readily scene that the use of NRT's balances the harm to the benefit and that the use of these products is not for an indefinate period of time like the e-cig. So it is that not that the clinical trials of approved drugs like Nicotrol dismissed the carciniginic by-products, rather they weighted the risk to benefit for short term use of these products in an effort to get the patient off of cigarettes.
On the otherhand the e-cig is marketed for an "indefinate use" time and hence must withstand the scrutinity of these by-products being induced over a long period of time by human consuption.
Sun
Agreed that if e-cigs do not go the NRT route, then long term consumption becomes an issue. What I don't understand is why the minuscule amounts of nitrosamines found in the liquid (not in the vapor!) are even an issue. Nitrosamines are consumed by most Americans every day in much larger quantities than found by the FDA in e-cig liquid.
From Wikipedia:
"Food
Nitrosamines are produced from
nitrites and secondary
amines, which often occur in the form of
proteins. Their formation can occur only under certain conditions, including strongly
acidic conditions such as that of the human
stomach. High temperatures, as in frying, can also enhance the formation of nitrosamines. These cooking styles may be responsible for thousands of cases of colon cancer per year across the world. The presence of nitrosamines may be identified by the Liebermann's reaction.
[1]
Under acidic conditions the nitrite forms
nitrous acid (HNO2), which is protonated and splits into the
nitrosonium cation N≡O+ and water: H2NO2+ = H2O + NO+. The nitrosonium cation then reacts with an amine to produce nitrosamine.[
citation needed]
Nitrosamines are found in many foodstuffs, especially
beer,
fish, and fish byproducts, and also in
meat and
cheese products preserved with nitrite
pickling salt. The U.S. government established limits on the amount of nitrites used in meat products in order to decrease cancer risk in the population. There are also rules about adding
ascorbic acid or related compounds to meat, because they inhibit nitrosamine formation.[
citation needed]
[edit] Consumer products
Nitrosamines can be found in
tobacco smoke and
latex products. A test of party
balloons and
condoms indicated that many of them release small amounts of nitrosamines.
[1] However, nitrosamines from condoms are not expected to be of
toxicological significance."
Read the ingredients on a pack of bacon or hot dogs! They (and many other foods) are loaded with sodium nitrite. Guess the FDA will have to ban beer and party balloons too.