The report finds fault with the njoy study design, which used the FDA approved Nitrol as a control.
The tobacco-specific metabolites (TSNAs), which are metabolites of Nicotine and are known carcinogens (nitrosonicotine or NNN and methylnitrosamino NNK), were found in the e-liquid but in detectable BUT NOT measurable amounts. Keep in mind that some of these same metabolites are even found in cooked food, especially those involving combustion. It is unclear how at these detectable amounts, they would have an effect if inhaled. Although Nicotine does not cause cancer from any empirical research I have read, these impurities may have long term effects on those who inhale eCigs. The author's case in point from her post is that although eliquids may be used from FDA-approved ingredients for human consumption, are they safe for inhalation? Lung diseases in factory workers where these very chemicals are processed are a concern and merit study. Further toxicity studies should also use animal testing for this very reason. Yes, although PG is used in medical-device and prescription inhalers and even fog machines, there are other food-grade additives we use too. What is the bio-availaibility and affect of inhaling them?
And furthermore, what about nicotine delivery? How much are you inhaling per "puff?" When you buy your ejuice, does the vendor carry out testing on their batches, or do they "wing it?" The NJOY cartridges did not deliver a consistent amount of nicotine between cartridges, unlike the FDA-approved inhaler Nitrol.
For the FDA, these are all un answered questions that if eCigs are to be regulated as nicotine delivery devices, will have to be addressed. It's a double-edged sword. Do we want them to be studied and legitimatized? Or continue to watch poorly designed study after study, and fear mongering article after article, pointing to these unknowns and scaring potential converts into staying SMOKERS, and it is WELL documented that the act of cigarette combustion leads to a myriad of health risks, both short term and long term from the 4,000 plus (including MANY carcinogenic) chemicals present.
As the author concludes, "The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY
products rather than reason for concern."
The author is not stating that in spite of what is in her opinion are indicators of regulatory acceptability, that eCigs are "safe" and her anaysis of the FDA's NJOY study should not be construed as such. THAT is the point of her above post. However, her report gives actionable recommendations for design and focus in future studies to further demonstrate such human safety.
Right now you can see how dismissive the FDA is of the relative safety of eCigs (which we all find rather baffling compared to the alternative of SMOKING), but put on their hat for a moment; they are all about empiricism. We need studies, and unfortunately strong lobbies, if we are going to gain legitimacy and no be lumped together with combustible forms of tobacco delivery.
For further reading if any of my fellow ECFers are interested, here are the known carcinogens found in cigarette smoke: http://en.wikipedia.org/wiki/List_of_cigarette_smoke_carcinogens A few of these metabolites/impurities were found in detactable i.e. trace but not measurable amounts in the NJOY liquid.
My own thought too is that eCig and liquid manufacturers should be developing their own standards of testing to "police themselves" and to further legitimatize what is growing far beyond a cottage industry now.
The tobacco-specific metabolites (TSNAs), which are metabolites of Nicotine and are known carcinogens (nitrosonicotine or NNN and methylnitrosamino NNK), were found in the e-liquid but in detectable BUT NOT measurable amounts. Keep in mind that some of these same metabolites are even found in cooked food, especially those involving combustion. It is unclear how at these detectable amounts, they would have an effect if inhaled. Although Nicotine does not cause cancer from any empirical research I have read, these impurities may have long term effects on those who inhale eCigs. The author's case in point from her post is that although eliquids may be used from FDA-approved ingredients for human consumption, are they safe for inhalation? Lung diseases in factory workers where these very chemicals are processed are a concern and merit study. Further toxicity studies should also use animal testing for this very reason. Yes, although PG is used in medical-device and prescription inhalers and even fog machines, there are other food-grade additives we use too. What is the bio-availaibility and affect of inhaling them?
And furthermore, what about nicotine delivery? How much are you inhaling per "puff?" When you buy your ejuice, does the vendor carry out testing on their batches, or do they "wing it?" The NJOY cartridges did not deliver a consistent amount of nicotine between cartridges, unlike the FDA-approved inhaler Nitrol.
For the FDA, these are all un answered questions that if eCigs are to be regulated as nicotine delivery devices, will have to be addressed. It's a double-edged sword. Do we want them to be studied and legitimatized? Or continue to watch poorly designed study after study, and fear mongering article after article, pointing to these unknowns and scaring potential converts into staying SMOKERS, and it is WELL documented that the act of cigarette combustion leads to a myriad of health risks, both short term and long term from the 4,000 plus (including MANY carcinogenic) chemicals present.
As the author concludes, "The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY
products rather than reason for concern."
The author is not stating that in spite of what is in her opinion are indicators of regulatory acceptability, that eCigs are "safe" and her anaysis of the FDA's NJOY study should not be construed as such. THAT is the point of her above post. However, her report gives actionable recommendations for design and focus in future studies to further demonstrate such human safety.
Right now you can see how dismissive the FDA is of the relative safety of eCigs (which we all find rather baffling compared to the alternative of SMOKING), but put on their hat for a moment; they are all about empiricism. We need studies, and unfortunately strong lobbies, if we are going to gain legitimacy and no be lumped together with combustible forms of tobacco delivery.
For further reading if any of my fellow ECFers are interested, here are the known carcinogens found in cigarette smoke: http://en.wikipedia.org/wiki/List_of_cigarette_smoke_carcinogens A few of these metabolites/impurities were found in detactable i.e. trace but not measurable amounts in the NJOY liquid.
My own thought too is that eCig and liquid manufacturers should be developing their own standards of testing to "police themselves" and to further legitimatize what is growing far beyond a cottage industry now.
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