Excellent balanced HuffPo article 1/9/14 - interesting FDA comments

Discussion in 'Media and General News' started by Roger_Lafayette, Jan 21, 2014.

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  1. Roger_Lafayette

    Roger_Lafayette Guest

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    ****************************************************************************** authored by Lynn Kozlowski, who's the Dean of the School of Public Health and Health Professions at SUNY Buff. (Those of you who are keeping track of the credentialed experts on our side can add his name to that of Micheal Siegal.)

    I was intrigued by:
    Which lead me to: Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer fact Sheet and then to Section 907 of the Federal Food, Drug, and Cosmetic Act - Tobacco Product Standards (sec. 907 of the FDCA, the Food Drug and Cosmetic Act):

    Right now, it's not clear to me exactly what this means in the context of e-liquid restrictions, but it does suggest to me that the FDA doesn't have the authority to ban interstate sales of vaping hardware.

    (That said, I think sometimes there's an understandable tendency to obsess over the FDA, since they once tried to ban PVDs. Congress, of course, can probably do whatever it likes.)
     
  2. Barbara21

    Barbara21 Moved On

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    One thing from the article that I thought was interesting...

     
  3. Roger_Lafayette

    Roger_Lafayette Guest

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    Yes Barbara, my understanding is that this was precisely what the FDA unsuccessfully argued back in 2010, when it attemped to ban PVDs.

    You might take a look at this NYT article: *************************************************************************************************************

    I believe what the court found was that PVDs are (non-therapeutic) tobacco products for purposes of the FDCA, and therefore the FDA lacked the authority to ban them. Presumably this applies to e-liquids as well.

    Subsequent rulings have held that the FDA couldn't ban importation of PVDs and e-liquids, therefore (?) they also lack the authority to ban interstate sales.

    However the FDA may regulate both, which is why I believe many observers anticipate that all flavorings except tobacco flavorings (i.e. flavorings that are intended to taste like real tobacco) and menthol will be banned to protext children. (Yeah, like flavored alcoholic spirits are banned too, right? :rolleyes: This is exactly what ocurred with analogs.

    But let me emphasize again - IMO the real dangers are (1) legislation, both by states and nationally; and (2) taxation (also both at the state and federal levels). I ran the numbers for e-liquid taxation here: ****************************************************************************************************************

    Of course once states start taxing e-liquids, Congress will likely oblige them by banning importation and interstate sales - which also happened w/ analog ciggies.

    (Some people think such a ban will be ineffective because e-liquid is so much more compact than analogs ... I have my doubts. After all, they can keep liquid illegal drugs out. Besides, who wants to be charged with tax evasion? I've also heard stories to the effect that state departments of revenue sent huge bills to people who purchased analogs interstate via the 'net :grr:
     
  4. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    What's the line? "I don't usually read/watch ..... but this isn't that bad"... Kozlowski isn't Michael Siegal, the 'balanced' approach includes some regulation and Kozlowski could be responsible for the "wild west" tag from his article in June '13:

    http://www.huffingtonpost.com/lynn-...ttes_b_3492528.html?utm_hp_ref=healthy-living

    As far as style goes - compared to others, he's the 'weaseling/waffling' kind. His focus is stopping cigarette smoking rather than personal freedom, but if personal freedom was his focus, he wouldn't be writing for HuffPo.

    He's more than 'ok' on the regulation of cigarettes and looks at ecigs only as a viable alternative to that end, although he considers the 'information' out there on ecigarettes is 'confusing'. "Web searches find a tangle of pro, con or undecided views, with examples of encouraging and discouraging pieces even within The Huffington Post." He's right on that last part.

    Kozlowski will never go where Jeffery Tucker did here, in the 'cold dead fingers' article:

    "That’s the theory, but then there’s the reality: nothing the state does that is worth doing cannot be done better by people themselves. That’s especially obvious in our time when the forces of innovation and progress are entirely on the side of markets, while governments are left behind to wallow in their own bureaucratic and politicized mire. Given this, what are states to do?

    The goal is always and everywhere control. They override our free choices and replace them with their own will. That necessarily means reducing the quality of our lives. And this they have done in nearly every area — they wreck consumer products daily, shut down websites we love, override innovation, harass entrepreneurs, tax the successful, and otherwise try to hold humanity back as much as possible."


    You can have my e-cig when you pry it from my cold, dead fingers | The Daily Caller
     
  5. Roger_Lafayette

    Roger_Lafayette Guest

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    Kent, we'll have to agree to disagree on the Q of regulation.

    My sense is that letting people buy crappy cheap e-liquids with diethylene glycol in them may eventually lead to a complete ban on PVDs. (And frankly I'd feel a bit safer if I knew that I could do at least some price-based comparison shopping, instead of having to stick with the larger, well-regarded - and more expensive - e-liquid vendors.)

    At the very least the lack of regulation (and the presence of diethylene glycol in cheap e-liquids) will result in more and more "hit job" studies that encourage people to argue that PVDs are more dangerous than analogs, which is the current line being pushed by the ATNZs: c.f.: ************************************************************************************* by Dr. Siegal.

    (What if health insurance companies decided that vapers deserve higher premium surcharges than those which are currently leveled on analog smokers? Currently this is probably prohibited by Federal law, but enough "hit job" studies could change that.)

    I'd rather have half a loaf than none at all: I've smoked analogs for four decades, and don't want to be forced to go back (or quit, which I don't think I could w/o PVDs). Besides, I enjoy vaping :)
     
  6. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    Pretty sure the diethylene glycol 'incident' was one carto in the 2009 FDA batch that they got from one vendor. The market as it does with knowledgeable vapers work this out as it has done here on mulitiple occasions. The idea that 'not everyone reads ECF' doesn't work with me as I'm a Darwin awards type. Ignorant (those who don't or refuse to get informed on stuff they use) people will pay for their ignorance or for their 'education' to where they become better consumers through the best teacher in the world - their own mistakes - without the help of gov't.

    IOW, agree to disagree :)
     
  7. Roger_Lafayette

    Roger_Lafayette Guest

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    I think there may have been more, but your general point stands that these were isolated incidents.

    Unfortunately we'll never hear the end of it.

    C.f. the Indy Star hit job article that I just posted about yesterday in this area (in which the author said that PVDs "contain" diethelyne glycol. :grr:
     
  8. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    It's the thing that 'regulator types' cling to. Why I'm not one.
     
  9. tommy2bad

    tommy2bad Super Member ECF Veteran

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    If I recall correctly their were several cartos but all from the same batch. Their was none found in other cartos from the same company. The likely cause was contamination on the outside of the cartos. Anyway the cartos were from a company that's no longer in business. No diethelyne has ever been found since.
    I still cant get the continued life in this factoid but it might have to do with it being the only one they found that would be part of the public consciousness since the French Wine scandal from a few years ago where some producers used diethelyne glycol as a preservative in their wine, accidently or on purpose I don't recall, more of a Sam Adams man myself.
     
  10. Roger_Lafayette

    Roger_Lafayette Guest

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    Our grandchildren will still be hearing about that one long after we're all dead. And their grandchildren, etc.

    I'm about 99% sure that I found it on: no-smoke DOT org/document.php?id=794 ... they've done a pretty thorough job of providing resources for hit job articles.

    As I think I said before - lots of people with letters after their names can advance their careers that way (or build their practices if they're MDs, etc.). Ditto lazy reporters.

    It's too bad we don't have a little web page somewhere that summarizes all the bogus allegations and responses to them.
     
  11. sonicdsl

    sonicdsl Reviewers Mgr
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    CASAA.org has some of that I believe

    Sent while Moderating ECF via Tapatalk 4
     
  12. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    More on this and concepts regarding regulation.....

    In the same way that not everyone reads HuffPo, not everyone listens to Rush Limbaugh, but in the first hour today (those who have 24/7 membership - check out the audio), he made some good points just as the HuffPo piece had some good points. I know not everyone will agree with the whole piece....

    Our Future Hinges on Our View of Freedom - The Rush Limbaugh Show

    ... but his comments on regulation are very close to what I was referring to earlier.

    "In the United States, we as citizens presume that everything is legal until a law is written making it illegal. It's something that we're taught, but it's also something that we just assume. So important is freedom to us, and so adequately, precisely defined and spelled out in our founding documents, all men are created equal, endowed by their creator. So we're born free, we are born yearning to be free. That's the natural spirit, the natural human spirit, and we just assume everything's legal until there's a law saying it isn't.

    But you go to Europe and many other parts around the world, and the presumption is just the opposite. It is that everything is illegal until there's a law making it legal. And that, to me, is fascinating. I think there's no question about it. It actually illustrates why and how so many people are totally subservient to the state. When you assume as an individual that everything is illegal until somebody makes it legal, you are essentially denying -- whether you know it or not -- the basic tenets of freedom as you are born. It also leads to statism. It leads to all-powerful governments. It leads to people giving up freedom and assuming, in fact, that they never had it, that freedom is what is given to them by the state. That's never been us. "

    "I think our future hinges on how the people of our country view freedom, and if more and more of them adopt the European attitude, which is... See, they get the order wrong here. If they assume that everything is illegal until a government or a Congress or a law comes along and makes it legal, then what is their starting point? Their starting point is, they have no freedom. The only freedom they have is that bestowed upon them by the state, by the central authority, by the munificence and the magnificence and the goodwill of the state."

    A bit later in the audio, but not in this transcript, he mentions ecigarettes "The same anti-smoking Nazis that are now invading e-cigarettes.... " and refers to a recent article and some of his personal experience in using ecigarettes....
     
  13. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    They do and that 'update' by Bill Godshall I linked above, also is a good source for 'debunking'.
     
  14. Vocalek

    Vocalek CASAA Activist ECF Veteran

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    No. There are NOT more. Furthermore, the hazards of "diethylene glycol" (DEG) are a non-issue.

    The FDA's "testing" in 2009 was geared toward trying to find something hazardous. When they couldn't, they decided to spin the results to make things sound hazardous. One of the 18 cartridges tested was found to contain 1% DEG. You can verify this yourself by reading the report: http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf

    Note that the paragraphs that are labeled "Simulated Use" refer to what was found in the vapor, while "Whole Cartridge" refers to what was detected in the liquid. Note that the one sample that contained DEG was tested as a liquid. (Each sample could only be tested as either a liquid or a vapor, because the testing destroys the sample).

    The FDA failed to find anything at all hazardous in the vapor. DEG can be hazardous if you drink it. But you have to drink a lot of it within a 24 hour period because it clears from the body quite rapidly. Rats need to receive 50 mg per kg of body weight to exceed the "no observed adverse event level" (NOAEL). When dealing with a 1% solution, a one-ml cartridge would contain 10 mg of DEG. You'd have to drink 5 one-ml cartridges full of liquid for each kg you weigh. How likely are you to quaff over 400 cartridges worth of e-liquid in a single day?

    However, for obvious reasons, people don't make a habit of drinking e-liquid. To my knowledge, DEG has not been found to be poisonous via inhalation.

    The FDA's press release is a masterpiece of propaganda. DEG is mainly used as a solvent, but the FDA spin-doctors called it "an ingredient used in anti-freeze" because they knew there had been many poisonings of pets and children before the makers of standard automobile antifreeze switched from using ethylene glycol to propylene glycol, which is non-toxic. The FDA spinners also used loaded words like "carcinogens" and "toxins" and ignored the rule that "the dose makes the poison." What that means is that in small enough amounts, a potentially toxic substance is harmless. In large enough amounts, a normally perfectly safe substance can be deadly--even water.

    You may be unaware of this, but the "carcinogens" they found were Tobacco-specific Nitrosamines (TSNAs). Because the pharmaceutical-grade nicotine used in e-liquid is extracted from tobacco, there may be tiny traces of TSNAs in it. In fact, you might be very surprised to learn that TSNAs are found in several of the FDA-approved nicotine products such as the patch and nicotine gum. What's even more surprising is that the amount in a nicotine patch is about equal to the amount in 18 mg/ml e-liquid. See this report:

    http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

    See "Comment 1)" under Table 2.2 on page 7.

    So if the patch isn't known to cause cancer, it seems unlikely that e-cigarettes would so so. In point of fact, modern Western smokeless tobacco products, which have not been found to increase the risks of any type of cancer, contains much higher amounts of TSNAs.

    To get back to DEG, the fact that it was found in an entirely non-harmful amount in one sample, one time, has been inflated by anti-nicotine/anti-tobacco writers who turn "one" into "several" without a trace of shame.

    But even if there were some DEG in every batch of e-liquid, that would still be a non-issue, since it doesn't occur in the vapor.
     
  15. Orb Skewer

    Orb Skewer Ultra Member ECF Veteran

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    Planted evidence ?
     
  16. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    Thanks Elaine.
     
  17. Roger_Lafayette

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    Vocalek and Kent, thanks for your replies. No, I wasn't aware of this DEG stuff that you just posted. But from a PR standpoint, I think we could probably use some sort of "debunking" FAQ (so-to-speak) that contains links and analysis which allow the casual reader to "drill down" to whatever extent they'd like.

    For example I just posted: ******************************************************************************************************************************** in the CASAA area, because I couldn't find anything like it on the web site. At 250 words, it's terse enough for a standard letter to the editor (if hobbled a bit in terms of elegance by the length. Perhaps CASAA could have a version that was maybe twice the length (with links to longer articles) for debunking. And so forth.

    The issue in my mind isn't that we don't have the kind of good information in your posts or on blogs like Dr. Seigal's or Bill Godshall's ... it's there, and it's of wonderful quality. But if I don't miss my guess, our adversaries seem to be considerably more effective at messaging than we are.

    In other words, this kind of factual "ammunition" is of much less value without an effective "delivery system," IMO. We can't ask the general public (or an editor or a cub reporter) to spend hours and hours clicking on links and pouring through studies ... they just won't do it, and they'll stick to the anti-vaping sound bites. (Especially when they don't smoke or vape, and probably feel as if they'd be sticking their necks out by doing anything that bucks the trend.)

    By the same token, we also need a series of "delivery systems" which can be effectively used by CAASA and/or vaping activists when posting online and/or writing editors to the editor, and/or when speaking to elected officials.

    Perhaps I don't know where to look, but I'm just not finding that kind of thing out there on CAASA's site or anywhere else?

    Based on the rubbish that I'm finding every day just by Googling "e-cigarettes" with a temporal limit (e.g. last 24 hr.s), what we are seeing here is a rapidly-hardening concrete web of mistatements, exaggerations, and outright lies. And the more the meme grows, the worse things are going to get.

    We need all the tools to fight back that we can fashion - the truth by itself may not be enough, unless it's in a form that can be more easily deployed. Sometimes the "messaging" matters as much or even more than the "message" when it comes to results. And I think this may be such a case.
     
  18. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    The links in the 'update' and other areas of CASAA are for us to inform the 'general public, editors, cub reporters' knowing they aren't going to do their own groundwork. "Reporters" these days are merely the 'steno pool' for the administration and it's agencies. Perhaps CASAA and Bill G. need more organization for you. Here's a few links you may like:

    http://......................./top-20-rebuttals-to-win-an-e-cigarette-debate

    Lies | Anti-THR Lies and related topics

    About the blog | Anti-THR Lies and related topics

    http://casaa.org/uploads/8_Biggest_Electronic_Cigarette_Myths.pdf

    the first link is blocked/censored here for some reason. It's ecigarette reviewed.com without the space of course....
     
  19. kristin

    kristin Accessories Supplier ECF Veteran

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    CASAA has some pages and handout material that can help:

    Electronic Cigarette FAQS

    http://casaa.org/uploads/CASAA-Ecig-TriFold-Brochure.pdf

    And as far as contacting legislators, we give "talking points" in our Calls to Action. We also help people in writing their testimony at hearings and letters to the media.

    We have avoided doing "template" emails for a reason. When a legislator sees the same email 500 times, it proves ineffective. They write it off as not coming from constituents. Personal stories and emotional pleas have shown to be far more effective. We've also seen vapers "written off" in comments on articles because they are all "parroting" the same thing. Non-vaping readers see it as a spam effort and interpret it as coming from "the industry." It's just too odd to people that the vaping community could be so informed and organized. (They never came up against the same passion and fervor with smokers. There was no percieved "smoking community" to compare to. They think its just "astro turfing.")

    But CASAA is currently working on some comprehensive, informational "booklets" that will include all of the counter-points in a clean, easy-to-read format. It's going to be a bit of time before those are completed, though.
     
  20. Roger_Lafayette

    Roger_Lafayette Guest

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    Thanks, Kirsten. Please let me know how I can serve most effectively.
     
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