Responding to FDA deeming proposal - Please wait!! - Page 2
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  1. #11
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    Ok ill wait, im ok with that. Good things come to those who wait.


    Vapeing for Freedom


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    Default The battlefield has shifted - time to adapt

    The ANTZ strategy has changed: they are going for "quantity at the expense of quality" for their own comments (not that their comments had and quality to begin with, other than the color brown that is): ANTZ suggestions on FDA comments....

    In light of these developments, I've decided to submit single-issue micro-comments (1 page or less) to the FDA docket on a daily basis, from now until the comment period is closed. Of course I will also continue to participate in the CASAA commenting efforts, in addition to my own micro-comments.

    Here are a few examples of single-topic comments that I plan to send in the next few days, and the scientific evidence that exists to debunk TCI myths and reinforce the facts:
    - Gateway: the ASH findings from England, Wales, and Scotland + the Harvard study ... √
    - Toxicity of juice: ECITA ejuice report ... √
    - Cardiac effects: study by Dr.F ... √
    - No evidence: recent study by Zyoud
    - Exposure to users and by-standers: Burstyn systematic review
    - Flavors: Dr.F's study
    - Financial conflicts of interest: TMSA and tobacco bonds
    - Big Pharma Conflicts: lobby against ecigs and ads
    - Lying politicians: for the children
    - Exhaled vapor: Romagna 2012 study
    - Risk: inappropriate regulatory action
    - Appropriate policy response: Nitzkin commentary
    - Junk Science from TCI: Bernd Mayer blog, and Dr.F
    - Youth Smoking: survey from France
    - Nicotine is not addictive: per the post below by DC2


    Here's the link to the comment page:
    Regulations.gov

    I'll add more items to the list above as I think of them, but please feel free to make suggestions. And definitely I urge you to submit your own micro-comments.

    A few examples will be posted on my blog: http://www.e-cigarette-forum.com/forum/blogs/drma/
    Last edited by DrMA; 07-13-2014 at 03:32 AM. Reason: more ideas; added checkmarks for those sent
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  3. #13
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    Quote Originally Posted by DrMA View Post
    I'll add more items to the list above as I think of them, but please feel free to make suggestions.
    Some research on the seemingly minimal addictive potential of nicotine when divorced from tobacco...

    Here is information from a study by an Arizona State professor emeritus...
    Professor: Nicotine does not cause cigarette addiction | The State Press - An independent daily serving Arizona State University

    “It’s time to get our heads straight,” Killeen said. “What causes the tremendously addicting power of cigarettes is the drug cocktail of nicotine,” he said, not nicotine itself.

    And here is a recent study from the Institute of Environmental Science and Research...
    Nicotine Is Not the Sole Addiction Causing Agent in Cigarettes

    Penelope Truman, from ESR (Institute of Environmental Science and Research) presented a study at this week's Smokefree Oceania conference in Auckland, New Zealand. She conducted this study on rats using pure nicotine and tobacco particulate matter (TPM) along with cigarettes and roll- your-own RYO/TPM and found that the rats were more eager to get a dose of non-nicotinic cigarette especially RYO/TPM than doses of cigarettes containing pure nicotine.


    And you might want to check these out too...

    Growing List of Positive Effects of Nicotine Seen in Neurode... : Neurology Today
    Obviously the results of small studies often aren't replicated in larger studies, but at least nicotine certainly looks safe. And we've seen absolutely no withdrawal symptoms. There doesn't seem to be any abuse liability whatsoever in taking nicotine by patch in non-smokers. That's reassuring.”
    Nicotine treatment for ulcerative colitis
    No withdrawal symptoms suggesting nicotine addiction have been reported either after 4–6 weeks of therapy in short-term studies, or after a period of up to 6 months in the only long-term study available.

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    Great stuff DC2 and Doctor

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    Default

    Excellent idea, DC2! added to the list above. Thanks and keep them coming.
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    DrMA likes this.
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    Default

    Looks like I can't edit my post above anymore... so I'll add new topics in new posts.

    - Regulation as consumer products: new publication by Dr. F
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    Hey doc, If you want to start a new thread for this, I'll sticky it. Might even be a good one to set global in the next week or two.

    Cheers,

    SJ

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    Thanks, SJ.

    Is it possible to split this thread at post #12 and make the subsequent posts (12 and up) the new thread?

    Otherwise, please use this thread as the sticky: FDA Deeming Comments - I'm starting to be worried
    Last edited by DrMA; 07-14-2014 at 09:18 PM.
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    I'll sticky the "I'm starting to get worried" thread, and if you don't mind, will add your "single-issue comments" to your OP.

    Can you clear this up for me, though....

    The difficulty here is with respect to comment volume. From what I understand, there's no point having thousands of comments by vapers in the FDA comments, since these will simply be ignored/consigned to a generic "pile", unless they can assert new evidence, or assert existing evidence in a different fashion.

    The only real reason for adding to the FDA is if any new evidence can be added. So, I'm going to submit our research data, since this is new, primary data and anyone who feels they can add to the evidence base should do the same thing.

    I would submit, therefore, that any data that industry members can give should be included - consumption trends and so forth could well be important.

    The real bulk of vapers' activism should be, in my opinion, contacting their members of congress asserting that the PACT is not appropriate for e-cigarettes.

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