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Three German Court Rulings - E-Cigs and Liquids are Not Medicinal Products or Devices

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  • Closed Accounts Posts: 181 ✭✭Occam


    tommy2bad wrote: »
    Read the report, couldn't find any ref to the FDA 40 adverse reports. Is it in the refs at the end? I'm lost and a search turned up no results, that could be a spelling thing though. Care to help out with a page no?

    Page 9, running onto page 10 :

    "Since 2008, the U.S. Food and Drug Administration (FDA) has received 47 reports about side effects of electronic cigarettes. These included eight reports about severe adverse events "

    Searching a paper for bits that interest you does not constitute reading a report. You clearly did not read it.
    tommy2bad wrote: »
    I never said it was the case of death

    Responding, inline, and directly underneath my post, where I asked:

    "Where did the GCC report cite a case of death due to lipoid pneumonia caused by e cig smoking? " you wrote :

    "The reference is on page 8, it's to the Chest journal"

    But its not , that reference does not refer to a case of death, you are not telling the truth.
    tommy2bad wrote: »
    I said we have no evidence to prove it's addictive, not one human trial, some inconclusive tests on rats but that's all. See how this works?

    I'm unclear, do you think nicotine is addictive?


  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    Occam wrote: »
    Page 9, running onto page 10 :

    "Since 2008, the U.S. Food and Drug Administration (FDA) has received 47 reports about side effects of electronic cigarettes. These included eight reports about severe adverse events "

    Searching a paper for bits that interest you does not constitute reading a report. You clearly did not read it.



    Responding, inline, and directly underneath my post, where I asked:

    "Where did the GCC report cite a case of death due to lipoid pneumonia caused by e cig smoking? " you wrote :

    "The reference is on page 8, it's to the Chest journal"

    But its not , that reference does not refer to a case of death, you are not telling the truth.

    Thanks, yeah 40 reports 8 serious and then they admit no causal relationship. OK.
    Ignoring the rest because you seem to be picking a fight again and calling me a liar again. For the last time try reading the posts.
    http://www.boards.ie/vbulletin/showpost.php?p=86756367&postcount=44


  • Closed Accounts Posts: 181 ✭✭Occam


    tommy2bad wrote: »
    Thanks, yeah 40 reports 8 serious and then they admit no causal relationship.

    Just to be clear about what they actually said, which you describe as admitting no causal relationship :

    "Although there ist not necessarily a causal relationship between e-cigarette use and the reported symptoms health concerns about electronic cigarettes are definitely justified "

    I thought you would be more surprised given your earlier assertion that there were no serious adverse reported at all !

    Also can you confirm that you think nicotine is NOT addictive? This is surely very relevant to the topic


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    I think Occam has a valid point, albeit without the tabloid hysterics and condescending tone.

    I came across this on another forum: (mods feel free to remove or edit, I don't know the rules on copy and paste from another forum)

    "Off a Dekang RY4 bottle, carrying the warning "Very toxic by inhalation, in contact with the skin and if swallowed" and bearing a skull and crossbones symbol, the ingredients are:

    Propylene glycol (75%) 3-methylcyclopentane-1.2-dione (2.5%) 1-malic acid (3%) 2.3.5.6 tetramethylpyrazine (1.5%) 2.3.5-trimethylpyrazine (0.3%) beta-dainescenaone (?) (0.2%) acetylpyrazine (0.2%) 2-acetylpyradine,ethanol (10%) rhodium (0.3%) vanillin (2.5%) ethyl acetate (0.5%) ethyl maltol (1.0%) 2-methyl-butyric acid (0.5%)

    Googling the components I find:

    Propylene glycol: Obvious.

    3-methylcyclopentane-1.2-dione (aka Cyclotene): Flavour: caramel; maple; smoky; coffee; nutty; bready; liquorice. Safe.

    Malic acid: Found in all fruits. Taste: mellow, smooth, persistent sourness. Universal flavour enhancer. Healthy.

    2.3.5.6 tetramethylpyrazine: Used in flavour concentrates. Dependant on manufacturer, tastes like: Cocoa, roasted peanuts, Coffee, fermented soybean and/or chocolate and is used to flavour these products. Safety rating: Harmful if swallowed.

    2.3.5-trimethylpyrazine: Same as above plus flavour: Caramel, Baked potato and peanut butter. Safety rating: Toxic if swallowed, irritating to respiratory system, eyes, skin. Flammable.

    Beta-dainescenaone: That’s what it looked like after I messed juice on the label, but probably beta-damascenone. Flavour: Intensely fruity odour with plum, berry, sugary and rose nuances. Also: woody, floral, herbal, green and fruity, spicy tobacco, apple; herbaceous; nutty; citrus; smoky; wine-like. Safety rating: Irritant. Irritating to respiratory system, eyes, skin.

    2-acetylpyradine ethanol: Flavour: Sweet, nutty, tobacco, popcorn. Safety rating: Toxic if swallowed, irritating to respiratory system, eyes, skin.

    Rhodium: Flavour: Sweet floral woody. Safety rating: Irritant. Irritating to respiratory system, eyes, skin.

    Vanillin: Synthetic vanilla.

    Ethyl acetate: Used in flavour concentrates and perfumes. Sweet, fruity, vinegary smell. Found in wines. Also a flammable solvent. Low toxicity.(This one is actually used in SOLVENTS)!!

    Ethyl maltol: Flavor enhancer used in wine, chocolate, vanilla, fruit flavoured drinks, pastries, candy, tobacco, cosmetics, and medicines. Used because it tends to mask bad tasting chemicals, and heightens richness and creaminess. Safe.

    2-methyl-butyric acid: Flavour: apple; apricot; cheese; chocolate; grape; fruity; pineapple; sour; strawberry; woody; wine-like. Safety rating: Corrosive: Harmful to skin and if swallowed."


    Now I imagine that everything that is known about these chemicals is based on oral consumption mainly and not on vaping, vaping may or may not cause some of them to have adverse effects or maybe none of them....so I think we should be vigilant and aware of what goes into our eliquids, and try and see if the manufacturers will state on the labels exactly what goes into them.

    I am still willing to bet that esmoking is ten times healthier than cancer sticks and the next juice I am trying out is Dekang RY4 :D


  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    @dePeatrick;
    The thing is thoes findings are from MSDS's (material safety data sheet) Theirs very little that wouldn't sound like a component of chemical weapons if you take that as evidence of harm. It's based on the chemical in pure form and the MSDS are for manufactures transporting and using barells of thees chemicals. All of which are used in food and medicines and already recognized as generally safe.

    The problem is that if we were to try to come up with something to replace smoking that had 0 risk and could be certified as 100% safe, we could not do it. (anyway that alternative exists, it's called not smoking) What we need to do is find something that reduces the risk to a statistically insignificant level. E-Cigs do that as far as we can tell. The bit we cant tell? Well is it worth waiting until we can? How many smokers will we deny a safer alternative until then.
    BTW only two flavorings are used in asthma inhalers as that's all have been certified as safe by inhalation. This means that using medical standards e cigs will come in two flavors, the same flavors as asthma inhalers.


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  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    Occam wrote: »
    Just to be clear about what they actually said, which you describe as admitting no causal relationship :

    "Although there ist not necessarily a causal relationship between e-cigarette use and the reported symptoms health concerns about electronic cigarettes are definitely justified "

    I thought you would be more surprised given your earlier assertion that there were no serious adverse reported at all !

    Also can you confirm that you think nicotine is NOT addictive? This is surely very relevant to the topic

    Not a bit surprised, the FDA have been trawling for a reason to condemn ecigs for a long time this evidence free list is exactly the king of tactic they use.
    I don't think nicotine is addictive, I know it is. Just how addictive is another question. Same as caffeine or heroin as claimed by the anti smoking propoganda?
    Personal experience, I wouldn't go half an hour without a smoke, I'll go 4 or 5 hours without vaping and not notice any cravings. I suspect consuming nicotine by inhalation is more addictive than by patches or gum but consuming nicotine by smoking is far more addictive due to the interaction with the other ingredients in cigarettes. Sometimes it hard to distinguish between addiction and habit.


  • Registered Users Posts: 745 ✭✭✭csi vegas


    Occam wrote: »
    Where did the GCC report cite a case of death due to lipoid pneumonia caused by e cig smoking? Please quote the relevant page, as I cannot find it. Did you read the paper?

    If they wanted to take the worst bits, would they not have included the case you mentioned where death was linked to e-Cig smoking?

    Not mentioning that case was evidence of balance not bias :rolleyes:

    *** Edit - not sure what happened with the quoting of csi vegas... can't see the post anymore?


    First of all - weren't you the eager beaver at around 4am this morning!
    - I posted then deleted within ten minutes because I needed to go back checking where I thought I saw a reference to a suspected death by that nasty practice of 'inhalation of oils'....So you saw my post when it went live?! Did you save my quotes on Works then reply at your time of posting (9.42am)? Not so ill-informed after all, am I? :D

    I basically made this mistake because of cross reading back and forth between the report and its references, Siegel's blogs and this from The Beeb http://www.bbc.co.uk/news/uk-england-12887335
    It's a little hard for me (as for many) to correctly intake online material as opposed to having a physical paper form in front of you, especially when you haven't saved that online info. Plus 4am, I mean, c'mon now...
    Also I'm a speed reader. Read War and Peace cover to cover one bank holiday Monday :D

    Below is where the notion of a suspected death leapt out at me:

    P18: 3.1.2 - Glycerine
    These concerns are not unfounded. The specialist journal Chest reports about a case study of a patient with lipoid pneumonia caused by glycerine-based oils from the aerosol of electronic cigarettes.

    P20: 3.2 - Side Effects:
    Since 2008, the U.S. Food and Drug Administration (FDA) has received 47 reports about side effects of electronic cigarettes.
    These included eight reports about severe adverse events (such as pneumonia, congestive heart failure, burns due to explosion of the product, possible infant death secondary to choking on an e-cigarette cartridge)

    An alarming finding was the detection of diethylene glycol in the liquid of one product.
    This substance may lead to serious adverse health effects and even to death if swallowed [FONT=Univers LT CE 45 Light,Univers LT CE 45 Light][FONT=Univers LT CE 45 Light,Univers LT CE 45 Light]101[/FONT][/FONT][FONT=Univers LT CE 45 Light,Univers LT CE 45 Light][FONT=Univers LT CE 45 Light,Univers LT CE 45 Light][/FONT][/FONT].
    It may be harmful if liquid gets into the mouth due to technical flaws when puffing at the electronic cigarette.
    (101) Schep LJ, Slaughter RJ, Temple WA & Beasley DM (2009) Diethylene glycol poisoning. Clin Toxicol (Phila) 47: 525- 535

    Side Effects cites 'reported cases' which were suspected of being directly or indirectly caused by e-cigs - TWO of which were obviously fatalities.
    In some of these, it does not-so-subtly hint that death was caused by inhalation of said nasty oils: the pneumonia, congestive heart failure for example.


    While I do agree with many points you make (all ingredients should be subject to stringent testing and controle - nobody here opposes that),
    I still have to assert that I think it was a deliberate mistake for the GCC to declare
    "Glycerine may cause lipoid pneumonia on inhalation"
    which was corrected to
    "Inhaled glycerine-based oils may cause lipoid pneumonia."
    And STILL it's not exactly good enough - they still try assert an unfounded 'correlation' between e-cigs and LP!
    They ought to do EXTENSIVE research alongside their peers to prove/disprove this before they go yelling it fom the rooftops to scare users and unfairly influence the already vehemently opposed who want to ban it all like some kind of Salem witch hunt before it's proven innocent or guilty.

    And to include it that a child died from possibly choking on a cartridge?!!!
    Of all the millions and billions of things that could be choked on!

    By saying so it certainly caused a minor rage in me. I don't normally involve myself in politics or any type of 'back-n-forth check the forums at 4am for smart replies kind of thing' but this really did píss me right off when I learnt of it and it's correction.
    It's like saying 'black is white - no wait, we mean black is black!... Or maybe it's grey!'

    There was once was war, now let there be peace!

    However I do think most will agree with the points I've made in retaliation in relation to Occam's arguements ;)
    I think I've summed it all up to what you guys are battling out these last few days. Hope so anyway!

    On a much lighter note: Samba - Are you really in Cuba? What with those Cuban-looking colours of your avatar 'n all :)




  • Registered Users Posts: 745 ✭✭✭csi vegas


    3oolbc.jpg

    Yes, let's! :)


  • Registered Users Posts: 745 ✭✭✭csi vegas


    tommy2bad wrote: »
    Found the original press release that caused the confusion over the lipoid pneumonia report.
    http://www.bbc.co.uk/news/uk-england-12887335

    Didn't even read any posts further than Occam's at top of page when I replied but amazingly I linked to the exact same article in my post. Also made a reference to that Chest report. Are you me in a parallel universe? :)


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    tommy2bad wrote: »
    @dePeatrick;
    The thing is thoes findings are from MSDS's (material safety data sheet) Theirs very little that wouldn't sound like a component of chemical weapons if you take that as evidence of harm. It's based on the chemical in pure form and the MSDS are for manufactures transporting and using barells of thees chemicals. All of which are used in food and medicines and already recognized as generally safe.

    The problem is that if we were to try to come up with something to replace smoking that had 0 risk and could be certified as 100% safe, we could not do it. (anyway that alternative exists, it's called not smoking) What we need to do is find something that reduces the risk to a statistically insignificant level. E-Cigs do that as far as we can tell. The bit we cant tell? Well is it worth waiting until we can? How many smokers will we deny a safer alternative until then.
    BTW only two flavorings are used in asthma inhalers as that's all have been certified as safe by inhalation. This means that using medical standards e cigs will come in two flavors, the same flavors as asthma inhalers.

    Medical inhalers do not heat the flavours and my guess is that heating them ie vaping, removes components (gunge on coils) and very unlikely that heating adds to them, maybe changes slightly.

    I would like to see all additives plainly labelled on eliquid though, just to add transparency to it. Then we can make up our own minds whether to ingest them or not and maybe discover that there are some additives we do and don't like.

    I feel sure though that the amounts if additives we end up with in our system from vaping is nothing compared to consuming the very same additives in processed food including the humble potato which produces one of the eliquid additives when baked :)


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  • Registered Users Posts: 7,807 ✭✭✭Calibos


    Occam, I'd still love to hear your opinion of the MMR Vaccine, Cellphone Towers/Masts and Aspartame to help us learn where you are coming from.


  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    csi vegas wrote: »
    Didn't even read any posts further than Occam's at top of page when I replied but amazingly I linked to the exact same article in my post. Also made a reference to that Chest report. Are you me in a parallel universe? :)

    What if we are? and occam is in charge :0


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    tommy2bad wrote: »
    What if we are? and occam is in charge
    :eek:


  • Registered Users Posts: 3,269 ✭✭✭DubTony


    dePeatrick wrote: »

    I would like to see all additives plainly labelled on eliquid though, just to add transparency to it. Then we can make up our own minds whether to ingest them or not and maybe discover that there are some additives we do and don't like.

    Interesting idea. I wonder if such a regulation was introduced would it also apply to cigarettes; and if it did would there be enough room on a cigarette pack to list all the ingredients?


  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    dePeatrick wrote: »
    Medical inhalers do not heat the flavours and my guess is that heating them ie vaping, removes components (gunge on coils) and very unlikely that heating adds to them, maybe changes slightly.

    I would like to see all additives plainly labelled on eliquid though, just to add transparency to it. Then we can make up our own minds whether to ingest them or not and maybe discover that there are some additives we do and don't like.

    I feel sure though that the amounts if additives we end up with in our system from vaping is nothing compared to consuming the very same additives in processed food including the humble potato which produces one of the eliquid additives when baked :)

    I myself have had reactions to some ingredients, shortness of breath, itchy dry skin, runny nose and sneezing. All sorted out by varying the amount of PG or VG and avoiding certain flavors. I miss desert ship but it had me gasping after a days use.

    Anyway this is about ze German courts saying that ecigs don't qualify as medicines. The lack of regulation specific to ecigs seem to be the problem, their is already regulation that can and should be applied to ecigs in the general consumer goods rules. The governments want for some reason unknown to make ecigs fit a medicinal model. We as consumers see how this will reduce our range of goods and also how it will reduce the appeal of ecigs as harm reduction alternatives to cigarettes. I came across someone suggesting cosmetic regulation as a better fit for ecig regulation. I'm not so sure about this myself but I can't see any government that has signed up to the WHO framework on tobacco control going for this option.
    Some amendments to the EU TPD have been proposed and they seem to want ecigs kept under tobacco regulations. A better option but still missing the point. Ecigs are not cigarettes or a cure for anything, they are a new category as half heatedly admitted by the EU in creating a new category NCP. All that needs to be done is list the appropriated regulations that are needed to further this product as a replacement for smoking.
    Nothing more is needed.
    I don't like the words 'light touch regulation' when I hear these words I parse them as 'carry on as long as we get our cut' in other words a stealth tax.
    What we need is approved ingredients, age restriction on sales to minors and standard tractability of ingredients and components.
    We don't need expensive testing or dose regulation. We don't need advertising restrictions beyond what already exist. We don't need public use bans based on unproven dangers or social modeling theories.
    All of these measures favor smoking over vaping while claiming to favor quitting over everything else. They do but that hasn't been a raging success, continuing down the quit or die road is a case of persuing a failing policy by failing harder.


  • Registered Users Posts: 3,269 ✭✭✭DubTony


    Seeing as how the discussion is about ingredients, I thought I'd share this. This ad appeared here on boards. It gave me a laugh. Cheaper because of rat crap?
    smiley-face-lol-emoticon.gif

    image_zpsdaf48afd.jpg


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    tommy2bad wrote: »
    I myself have had reactions to some ingredients, shortness of breath, itchy dry skin, runny nose and sneezing. All sorted out by varying the amount of PG or VG and avoiding certain flavors. I miss desert ship but it had me gasping after a days use.

    Anyway this is about ze German courts saying that ecigs don't qualify as medicines. The lack of regulation specific to ecigs seem to be the problem, their is already regulation that can and should be applied to ecigs in the general consumer goods rules. The governments want for some reason unknown to make ecigs fit a medicinal model. We as consumers see how this will reduce our range of goods and also how it will reduce the appeal of ecigs as harm reduction alternatives to cigarettes. I came across someone suggesting cosmetic regulation as a better fit for ecig regulation. I'm not so sure about this myself but I can't see any government that has signed up to the WHO framework on tobacco control going for this option.
    Some amendments to the EU TPD have been proposed and they seem to want ecigs kept under tobacco regulations. A better option but still missing the point. Ecigs are not cigarettes or a cure for anything, they are a new category as half heatedly admitted by the EU in creating a new category NCP. All that needs to be done is list the appropriated regulations that are needed to further this product as a replacement for smoking.
    Nothing more is needed.
    I don't like the words 'light touch regulation' when I hear these words I parse them as 'carry on as long as we get our cut' in other words a stealth tax.
    What we need is approved ingredients, age restriction on sales to minors and standard tractability of ingredients and components.
    We don't need expensive testing or dose regulation. We don't need advertising restrictions beyond what already exist. We don't need public use bans based on unproven dangers or social modeling theories.
    All of these measures favor smoking over vaping while claiming to favor quitting over everything else. They do but that hasn't been a raging success, continuing down the quit or die road is a case of persuing a failing policy by failing harder.
    I appreciate your honesty Tommy, it was first sold to me as having only three ingredients, PG, VG & Nicotene.....I now tell people that there are some additives and they may not all be safe, but definitely safer than the 8,000 in cigarette smoke.

    I Have not had any adverse reaction as yet apart from a dry throat which I put down to using too high a PG content, my OH commented at how much better my skin looked since starting vaping....at my age a serious compliment :):D

    I think the governments want a cut of the profits and will persue whatever way they can to get it as they slowly cop on that esmoking is going to be the future for the vast majority of smokers. I am astonished at the amount if people I know taking it up since I started 6 weeks ago.

    You are bang on the money in what you say about regulation, will be very interesting to see how this one plays out and what part the Internet will play in this one. I imagine it is true to say that the bulk of sales are done online?


  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    I Have not had any adverse reaction as yet apart from a dry throat which I put down to using too high a PG content, my OH commented at how much better my skin looked since starting vaping....at my age a serious compliment
    Oh I'v gotten that too and not just when herself was randy :)
    Loads of people have comment on how much my skin improved, I must have looked like ;
    18871380.jpg
    before I switched.


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    @DubTony, every time I see that I think of Banski....:p

    If-Graffiti-Changed-Anything-by-Banksy.jpg


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    @ tommy2bad...ha ha haaa.....so while I was struggling to learn how to put a photo up here you found my pic on the web....awwwww.....and that was when I was a young lad........:D

    Even funnier I misread that, thought you were saying that was how I looked......it was :) noticed any improvement in the *ahem* performance department since stopping smoking?


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  • Registered Users Posts: 4,255 ✭✭✭tommy2bad


    dePeatrick wrote: »
    @ tommy2bad...ha ha haaa.....so while I was struggling to learn how to put a photo up here you found my pic on the web....awwwww.....and that was when I was a young lad........:D

    Even funnier I misread that, thought you were saying that was how I looked......it was :) noticed any improvement in the *ahem* performance department since stopping smoking?

    One word! rabbits :D


  • Registered Users Posts: 1,363 ✭✭✭dePeatrick


    tommy2bad wrote: »
    One word! rabbits :D
    Yep......

    Bugs.jpg


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