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The real facts about FDA research

Discussion in 'Vaping Related But Doesn't Fit In a Category' started by brian yaeger, Aug 19, 2014.

  1. brian yaeger

    brian yaeger Member For 4 Years Member For 4 Years Member For 3 Years Member For 2 Years Member For 1 Year Member For 5 Years

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    The real facts about electronic cigarette research
    Posted by brian yaeger on 8/18/2014 to Vaping News & Story's
    [​IMG]
    The Real Facts On

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    FDA Research


    There are many research projects that are being done on what the health implications are when it concerns electronic cigarettes so I felt it was my job to give the facts about what the government has concluded so far and dispel all the myths. I have been wanting to write such a paper for a while now and being that I am an avid e-cig smoker I myself was curious to know what the FDA exactly knows and just how they plan to regulate them so I began poking around the internet and this is what I have found.


    The first report I came across was dated May 4, 2009 and was sent to Michael Levy who apparently works at the FDA as a supervisor on the regulatory counsel, office of compliance, Division of New Drugs and Labeling Compliance. Now that title seems real technical, but I can only hope that he is smart enough to hold that title and to see the real benefits behind electronic cigarettes.


    The primary subject of the paper that was submitted was electronic cigarettes, and the FDA had requested that the Division of Pharmaceutical Analysis evaluate just two types of e-cigs for their research. Their job was to find out just what type of impurities were in electronic cigarettes. This seems like a failure on their behalf being that there are plenty more than just two types of electronic cigarettes on the market.


    So what exactly is an electronic cigarette anyways and what is it made of? An electronic cigarette is an alternative nicotine delivery system that produces a vapor when a liquid is heated. There is no combustion what so ever in the process unlike your traditional cigarettes. It generally consists of three parts, a battery, coil, and a tank to hold the e-liquid. The e-liquid itself would be the only culprit that has any form of potentially harmful substances for the environment assuming you dispose of the battery correctly.


    The DPA was asked to quantify the amount of impurities in the e-liquid which contains propylene glycol and nicotine. There usually is some kind of flavoring extract to go along with all that, and vegetable glycerin in most cases. I am assuming they left those out of the equation when doing the research as I found no mention of it in this paper. They were specifically looking for the amount of tobacco specific nitrosamines (TSNA), ethylene glycol (EG), and diethylene glycol (DEG).


    The two specific test products used in their scientific research were NJOY e-cigarettes, and a Nicotrol Inhaler which both of these I personally have never heard of until today. It seems to me that this research is very limited in scope.


    They arrived at the conclusion that both of these products did contain nicotine in them. Wow, these guys are smart. They should hire them for more research. If you couldn’t tell I was being very sarcastic with that last remark. TSNA was detected in both products at very low levels. A lot lower than there their combustible counterparts.


    These test were conducted using ciga-likes which use a cartridge to deliver the nicotine to the body. The fact is that most people today are not using cartridge systems to get their e-cig fix. Again, I believe that this is a failure on the behalf of the FDA to provide a proper testing of what is actually being used on the market today. If they are basing their regulatory decisions on this paper than we are all in trouble.


    Now, let’s get to what exactly they have found inside these cartridges. Some of this stuff gets a little scientific so I will just reference what they have put down and if you are able to decipher it than that means you are smarter than I am.


    Whole Cartridge: Nicotine content by HPLC-UV

    Results, similar for both methanol extraction and 10% acetonitrile/1% phosphoric acid in water extractions, are shown in Table 1.

    Whole Cartridge: Tobacco Specific Nitrosoamines by LC-MS/MS

    The four major TSNAs include: N-nitrosonicotine (NNN), N-nitrosoanabasine (NAB), N-nitrosoanatabine (NAT) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) were analyzed for using LC-MS/MS and the results are shown in Table 1.

    Whole Cartridge: Tobacco Specific Impurities by GC-MS and GC-MS/MS

    Nicotine was detected in both products in all cartridges including samples identified as containing no nicotine. Samples were screened for possible tobacco specific impurities: cotinine, nicotine-N-oxide, nornicotine, anatabine, anabasine, pseudooxynicotine, myosmine, β-nicotyrine, and 1-methyl-3-nicotinoylpyrrolidine (MNP). Nicotine-N-oxide, nornicotine, anatabine, pseudooxynicotine and MNP were not observed in any of the samples. Results from cotinine, anabasine, myosmine, and β-nicotyrine are shown in Table 1.

    Whole Cartridge: Diethylene Glycol by GC-MS

    Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%.


    Like I said, all that gets a little too technical for my blood. There has been plenty more research conducted since that date. Just recently research was conducted by the World Health Organization that that electronic cigarettes were in fact a safe and healthier alternative to their combustible cousins which we are all trying to get away from.


    The scientist found no evidence that electronic cigarettes were harmful to the human body. You will have to bear in mind that no long term research of these products has been conducted because simply stated they just have not been on the market long enough to allow for such a thing.


    There also have been recent surveys of smokers that have found that when it comes to smoking cessation, and when it comes to which products to use to quit, electronic cigarettes were preferred by about 57% of all smokers while prescription drugs like Chantix held about a 39% favor among smokers. This research was conducted on about 20,000 smokers which is a pretty big number. In the end, electronic cigarettes remained the favorite of all the different ways one could try quitting. I find it very unfortunate that electronic cigarette companies, and vendors are not allowed to make any type of claims when it comes to cessation of nicotine. It is very obvious that these devices work.


    The battle rages on and on to who exactly will shine a non-biased light on the issue. On one side you have the proponents for electronic cigarettes who will off course tell you that they are better for you but where exactly is there knowledge coming from. For the most part these are all personal opinions. Most people have not set up a lab in their garage to test the health effects that come from these devices. I’m not saying that they won’t alleviate you from the addiction of nicotine because I myself have found them to be very helpful. I’m just saying that theses opinions by themselves will not hold water against the FDA when it comes to regulation. There need to be proof when it comes to the legality’s of the issue. I am happy to say that there is much being done in the way to help the electronic cigarette industry through avenues like CASAA.


    Scientist alone are not the only ones who are backing electronic cigarettes. It does not come to much surprise that the tobacco companies are also backing electronic cigarettes as a much healthier alternative. They know the financial implications that would come to burden if they did not jump on the bandwagon. They are also sponsoring their own research projects to help demystify the belief that e-cigs are dangerous seeing is how they own most of the market share. So I wouldn’t always jump to the conclusion that the big tobacco companies are hurting the vaping market. They may well in fact be helping us in the short term. Let me reiterate the word “short term.” It won’t be long before they try to stick their noses all the way into the vaping market crushing opponents like those who own small businesses.




    In conclusion, mush research needs to be done before the truth and the outcome come to light. It’s a guessing game at this point as to which side will prevail. Your guess is as good as mine. If you would like to continue to enjoy vaping for years to come than I suggest you get actively involved in the process. That is the only way that we will achieve the results that is wanted by so many electronic cigarettes enthusiasts like myself.
     
    Bold Vapor, Chowder and Scuba-Matt like this.
  2. Scuba-Matt

    Scuba-Matt Silver Contributor Member For 4 Years Member For 3 Years Member For 2 Years Member For 1 Year Member For 5 Years

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    Nice read. I'm more concerned with big Pharmaceutical companies putting the hurt on vaping. After all we have really hurt their products like the nicotine inhaler and others. If we all get healthier from vaping and are not smoking. That's less money spent on Pharmaceuticals down the road.
     
  3. UncleRJ

    UncleRJ Will write reviews for Beer! Staff Member Senior Moderator VU Donator Platinum Contributor Member For 4 Years VU Challenge Team ECF Refugee Reviewer

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    My personal opinion of the FDA studies......


    Chimp Finger.jpg
     
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  4. KKen

    KKen Silver Contributor Member For 4 Years

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    My personal opinion of who the FDA is...

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  5. brian yaeger

    brian yaeger Member For 4 Years Member For 4 Years Member For 3 Years Member For 2 Years Member For 1 Year Member For 5 Years

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    True. True
     
  6. Bold Vapor

    Bold Vapor Bronze Contributor Member For 4 Years Member For 3 Years Member For 2 Years Member For 1 Year Member For 5 Years

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    Excellent Post Brian
     
  7. brian yaeger

    brian yaeger Member For 4 Years Member For 4 Years Member For 3 Years Member For 2 Years Member For 1 Year Member For 5 Years

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  8. Kemosabe

    Kemosabe Bronze Contributor Member For 4 Years

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    i think that in addition to studying the eliquid itself, they might also be studying what affect the coil and wick have on the vapor when heated. minor amounts of metal, wick material etc might make its way into the vapor. we all know dry hits taste gnarly- they might be worth studying.
     
  9. Savage_46

    Savage_46 Bronze Contributor Member For 4 Years

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    I read an article months ago about a study that was done specifically on the byproducts created during vaping. Instead of looking at the "smoke" itself, they went for any materials in it. Metal, silica, and whatnot.... All they readings they found were well under the daily limits as mandated by OSHA.

    I don't remember who did it, or the article name & author. @UncleRJ, maybe you can help. It was posted or linked to on our other forum.
     
    Kemosabe likes this.

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