Fda news release

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TheIllustratedMan

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Reading the PDF document. It looks as if the FDA is trying to prove that these are not smoking cessation devices. I don't remember smoking everywhere EVER stating that these were smoking cessation devices. Even though some delivered more nic than labeled.. As a rule most were consistant with labeling... Inquiring minds wanna know what Big Brother will do now.

Why would they do that? It would give Judge Leon an avenue to rule against them in the SE/Njoy vs FDA case, and take the e-cig out of their regulatory hands.

A lot about what's happening here makes no sense to me.
 

tannerk

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Does the report say that or show that, or is this your supposition? Would be strange if true.

Yes it does... Following is copied from the report verbatum:

Whole Cartridges: Analysis of Tobacco Specific Nitrosamines by HPLC-MS/MS
... For the extraction, the cartridge was removed from the inhaler unit/atomization chamber. The fibrous material was removed from the cartridge using a pair of tweezers and both the fibrous material and the white plastic housing were placed in an Ehrlenmeyer flask. The flask was weighed and the weight of the fibrous material and white plastic housing were recorded....

Whole Cartridge: Diethylene Glycol by GC-MS

Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%.
Simulated Use: Sparging Apparatus

There is absolutely no reference to DEG...
 
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Sar

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... Tobacco kills 400,000 people a year in the US alone. 3.2 million world wide. Knowing those numbers I would have signed that damn paper years ago. ...
Well, from behavioral causes of death, smoking is shown to be the highest at 400,000, but right next to it with 300,000 deaths is diet/exercise (in)activity. And diet/exercise affects children too. Why would you ban one person's poison (tobacco) but not ban the other (burger)?
 

Bones

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  • Jun 3, 2009
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    Lets get those keyboards going - Feel free to use any parts of this that you choose.

    To: Nightly@NBC.com
    Subject: URGENT REQUEST FOR MR. BRIAN WILLIAMS REGARDING FDA STATEMENTS


    To Mr. Brian Williams,


    Hello Sir,


    Let me begin by saying that I believe you to be one of the few true journalists still serving in the profession. I have admired your work and watch your broadcast frequently. Just a couple of nights ago I watched you on the Daily Show with John Stewart. I always enjoy your appearances on his show and this one was no exception. In this appearance I was moved by your reflection on the life and work of Walter Cronkite. You stated that you had always wanted to be just like him. Within the constraints of the time you are afforded and the nature of present day broadcast news cycles, I believe you have gone a long way toward achieving this goal. I watched the story that you presented covering the Electronic Cigarette (E-cig) that aired earlier this week. I saddens me to inform you that in this piece you fell far short of your aspiration to emulate the man.


    I am a member of the E-Cigarette-Forum (ECF) that was featured in your report. The statements put out by the FDA did come out at a time when it seems your report was already prepared, so I will give you the benefit of the doubt for now. Your reporting of the statements made by the FDA in regards to the safety of the E-cig was very one sided and showed no evidence of investigative reporting. I have spent a tremendous amount of my time researching this issue over the course of the past four months. There are some very important factors that must be addressed when reporting on this issue. First and foremost, when dealing with this issue it is a misconception that the E-cigs are not as safe as users of the device have claimed.


    We tend to be a rather well educated and informed group and were never under any delusion that the E-cig was 100% safe. The reason that we have made an informed decision to use the devices is based on the fact that they are significantly safer than traditional tobacco cigarettes (analogs). There are over 4000 harmful chemicals in a tobacco cigarette. The FDA report points to 3 in the E-cig. Going by the FDA results the assertion that E-cigs are safer than tobacco holds true. What is even more significant is that similar chemicals are found in the FDA approved nicotine replacement therapy, Nicotrol. The FDA further dismisses the testing done by the New Zealand Health Department. This testing found similar results to the FDA testing yet made very different conclusions deciding that the E-cig is safer than a tobacco cigarette by a very high order of magnitude. The level of the offending components in the nicotine fluid (E-liquid) do not constitute serious risks to the user. This is overwhelmingly true when compared to the traditional tobacco cigarette. Again, I must point out that the E-cig is no more harmful than the highly touted Nicotrol device. It is also significantly less harmful than drugs like Chantix and Zyban. It is becoming apparent that the FDA, under political pressure from the American Lung Association and other anti-smoking groups, is not being clear or complete in the conclusions it is presenting to the public and is on a crusade to remove this viable option from the market. From my own personal experience of having smoked tobacco products for over 25 years, I can tell you that since switching to the E-cig I have noticed marked improvement in my health and well being.


    I watched an interview with Mr. Cronkite from 2003 just last night. He was being asked about the state of your industry today. He was not pleased with what he saw. He pointed to the trend toward news becoming entertainment. When confronted with the statement that the news organizations were simply giving the people what they want, Mr. Cronkite responded by saying, "We should not give the people what they want. It is our job to give the people what they need." He went on to say that what the people need is full and complete information in order to make informed and rational decisions about the issue at hand.


    In the name of Walter Cronkite, I beseech you to do just that. There are questions that must be asked in order to give the people what they need.


    What the FDA did not tell the media or the public, and what the American Lung Association failed to express alarm over, is the fact that nicotine replacement products themselves have been found to have detectable levels of tobacco-specific nitrosamines, including 4-(methylnirosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN). Both of these chemicals are consistently carcinogenic in laboratory animals and are widely recognized as carcinogens present in tobacco products. The question is not over their presence, rather it is about the level of concentration and how this compares to the traditional tobacco cigarette. There was nothing done by the FDA to show what levels of these chemicals are actually being absorbed by the user. The fluid was tested for contents only did and not include human or animal testing. In fact, it would be fair to say that the testing was deeply flawed and hastily conducted.


    These are questions that demand an answer:


    1- Given the finding that nicotine replacement products and electronic cigarettes both contain carcinogens, why is it that the American Lung Association is only calling for the recall of electronic cigarettes, not other nicotine replacement products?


    2- Why is the FDA allowing Chantix to remain on the market when we know that it has killed people?


    3 - Why would the FDA lab use the nicotine inhaler as a control specimen rather than a tobacco cigarette and refuse to test the inhaler for carcinogens? The nicotine in them is derived from the same source (tobacco) as that in the E-cig.


    4 - What are the levels present? The tests were done in parts per billion. This is normally done in parts per million. Why is that?


    5 - How does the E-cig compare to the traditional tobacco cigarette as far as health risk is concerned? This is the real issue at hand!


    I will give you links to much of this information at the bottom of this correspondence.


    Let me close by saying,
    I do sincerely hope that you will revisit this important issue of public health. In the name of your hero and a man that we all admired greatly, Mr. Walter Cronkite, I ask that you do the right thing and give the people what they need. You profess to aspire to his level of honest and thorough presenting of the news. Now is your chance to prove this to yourself and to the world on an issue that effects millions of lives.


    And that's the way it is!


    Thank you for your time and attention,
    XXXXXXXXXXX
    Austin, Texas






    New Zealand Health Study results - http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf
    Tobacco specific nitrosamines in new tobacco products - http://www.starscientific.com/404/st...0tsna in.pdf
    A wealth of valuable data gathered by an ECF member - Propylene Glycol Research Study Results
    FDA warnings about Chantix and Zyban - FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
    Tobacco Harm Reduction Site - Tobaccoharmreduction.org
    Blog site of a fellow ECF member - The Rest of the Story: Tobacco News Analysis and Commentary
     
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    palermo45

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    Your hypothesis is correct. It is also important to note that DEG was found only in liqud sampling (less than 1%) and not in vapor sampling.

    The toxicity data on MSDS and FDA own admission is given for a standard state (at 25 °C, 100 kPa). From FDA's report, liquid was heated to 60 °C.

    Since we are not drinking the liquid, The data on DEG toxicity and it's state (breakdown/reactions if any) we all should be looking for is at 60 °C.
    The entire findings of the FDA I would say are accurate and not fictional. However I would guess that if you used the same tests on thousands of everyday household items we use, you would also find minute amounts of toxins. The bottom line is that we need someone with true authority and strong medical knowledge who will simply state the obvious!! If you compare the average toxicity of an e-cig vs a regular cigarette, the e-cig will undoubtedly show much healthier! Regular cigarettes are known killer's so what is the true issue here? There is simply a lot of political power, blended with lies to misguide the public of the truth. That cocktail is more toxic and definitely more nauseating. Honestly,,where is the logic here? Show me one advertisment that tries selling to kids! That is so lame and without merit! Im tired of politics using the "marketing to children" approach. Regular cigs are pretty nasty and e-cigs really do not bother anyone. They are much cleaner for the environment and do not burn. No more thousands of nasty butts! No more nasty smelling smoke!! Wouldn't true anti cigarette advocates be jumping up and down if someone could instantly turn all regular smokers into e-smokers with the wave of a hand?? I would think so!!

    The one matter I do agree with is that the liquid needs to be manufactured in the USA and be done so with USP grade chemicals. This would at least inhibit any toxins stemming from a dirty environment. US manufacturers are responsible for what they produce so they are sure to get the formula correct every time or at least within reason.
     

    palermo45

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    Is it really that far-fetched to imagine an America where the FDA simply warns people of the risks of a product and lets them choose whether or not to use the products? Are we that much like little children that we need someone to hide the knives so we don't accidentally cut ourselves?
    What bakes my noodle is there is not a single documented case of anyone dying or getting sick due to e-cig use!! That is actually quite amazing, given the fact that the liquid does contain nicotine which is poisonous and assuming that half a million people in the US use e-cigs is even more amazing.
     

    Bones

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    What bakes my noodle is there is not a single documented case of anyone dying or getting sick due to e-cig use!! That is actually quite amazing, given the fact that the liquid does contain nicotine which is poisonous and assuming that half a million people in the US use e-cigs is even more amazing.

    Nicotine is not fatal in the amounts we are dealing with - Far from it -
    An e-cig puff only delivers about 10% of the nicotine found in an analog puff - You ever hear of anyone dying from a cigarette?(short term anyway) That is not the issue - The issue is that they are safer than analogs BY A LIGHT YEAR - No one here ever claimed them to be 100% safe - In the spirit of fairness - There has yet to be any long term use of e-cigs - It would far more amazing to me if anyone HAD died from them -
     

    bwood12043

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    I want to use the safest option I can, but I also find myself being realistic enough to know that from the moment of conception to the moment of death, nothing in our lives is 100% safe, NOTHING, not our food, not our cars, not our homes, our meds, our clothing, nothing, absolutely nothing is 100% safe.

    Now, our goal should be to reduce the risks in way we realistically can.

    I have been a very heavy smoke for over 35 years. The health problems were beginning to take effect, especially since reaching 50 yr old. I looked far and wide for an option or quit aid that worked for me. Tried them all, at great expense. Some worked a little, some not at all and some had adverse effects, one very serious adverse effects (Chantix). And the dissappointment and feeling of failure only heightened my psychological need for a smoke.

    One year ago next month, I decided to try the PV route. At first I was thrilled and it worked so well, I was elated. Then some rather stressful events happened, like being out of power for two weeks following IKE, then a death in the family, anyway, I resorted to a mix of PV and analogs..

    Now, I am quite proud to say it's been over six months since I have had an analog and I cannot tolerate the thought of going back, although I know that without the PV, I would end up goinig back, no matter how hard I tried.

    I have been conversing on phone and in email with my representatives, but they need more people telling their story. Newspapers and TV need more people telling real life stories, not just some reporters pandering to the FDA and their limited knowledge of what's really going on in the vaping community.

    I just hope that the PV community is able to get across to the "powers that be" in this thugocracy we live under how important these devices are to us. At 56, I have more experience and knowledge of the smoking addiction and the problems related to it than most of those in Congress.

    Please, get active, write, email, call, let them know how you feel, if you have a good doc report, tell them about it. My BP is down, my O2 sats are up, my lung capacity is improved, I am sleeping better, and that's just the health effects, does not even address the fact that my home is cleaner, my car is nicer, I don't offend others with nasty smoker smell, I am less stressed and less angered by the non-smokers getting in my face and trying to confront me. All around, life is much better. And I feel like a concerned, responsible community, although in it's infancy, is trying to unite to bring about a better product for all of us. Improvements are being made every day.

    Vape ON ! En Masse !
     

    Bones

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    The entire findings of the FDA I would say are accurate and not fictional.

    It is not the findings that should be questioned rather the conclusions and course of action they have chosen - Also the testing procedures leave much to desired - We are not comparing this stuff to distilled water - We are comparing it to TOBACCO -
     
    ... the liquid needs to be manufactured in the USA and be done so with USP grade chemicals. This would at least inhibit any toxins stemming from a dirty environment. US manufacturers are responsible for what they produce so they are sure to get the formula correct every time or at least within reason.

    The toxins come from tobacco.

    Sad to see the jingo stuff.
     

    Bones

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    Yea cause we have no dirt in the USA? - Honstley - This is not about where they come from - It's about the FDA - JC would have produced the same results before they removed the tobacco absolute - And the nicotine still comes from tobacco - When you test in parts per BILLION - you will find it - And if you are not buying from JC - You are buying from China - They are the only ones making it in the US -
     

    Bones

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    Is it really that far-fetched to imagine an America where the FDA simply warns people of the risks of a product and lets them choose whether or not to use the products? Are we that much like little children that we need someone to hide the knives so we don't accidentally cut ourselves?

    We don't have to imagine it - Look at all the FDA approved drugs that do exactly that - Or our old friend MR. Tobacco - Why is this different? Many here have already answered that -
     
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