CASAA Call to Prepare re FDA Regulations Comments
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    Exclamation CASAA Call to Prepare re FDA Regulations Comments

    CALL TO PREPARE

    CASAA has issued the first Call to Prepare in CASAA's Action Plan regarding FDA's proposed regulations. This Call to Prepare is your opportunity to begin laying the groundwork for your formal, substantive comment to the FDA.

    Consistent with our earlier instructions, we are asking consumers to continue to wait to file substantive comments for a few more days. We anticipate issuing the Second Call to Prepare early next week, which will provide guidance on further refining draft comments. The Fourth Call to Action (requesting consumers assemble their prepared thoughts and submit the comment to FDA) is expected to be issued towards the end of next week.

    CASAA: First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment
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    Thanks!

    There are a lot of issues that can (and will) be commented on, but I think CASAA extracted out some very good ones here.

    Some people have said that the FDA isn't concerned about 'personal stories', and while that is likely true, 'comments' are part of a gov't record, and while such stories can individually be dismissed as 'anecdotal', thousands of them, cannot.

    I, at one point, said that I may just end up sending Carl's piece on Black Markets. It sums up almost everything. imo

    Predicting the black market in e-cigarettes | Anti-THR Lies and related topics


    Re: flavor - their main 'weapon' right now... from earlier posts from the Senate HELP committee thread:

    Why Isn't Vaping the FDA Center for Tobacco Product's Biggest Ally?

    4. That many adult vapers love flavors and actually avoid tobacco and methol flavors to avoid the behavioral aspects of their smoking habit. And therefore, for adult vapers, more flavors are a positive aspect, that helps them move away from smoking.

    5. Adult vapers are affected, in a positive way, (see #4) by advertisements regarding flavors.

    6. That informed vapers, including the fact that all adults now know the downside of combustible tobacco, are not going to opt for the 4000+ chemicals in cigarettes over the @4 ingredients that make up eliquids, even though a few of those ingredients may contain some of the contaminants of cigarettes but at trace levels that even the FDA estimates, on average, as 9 times less than cigarettes.


    And going right at what Zeller claimed regarding his work on behavior and applying the 'flavor factor' into that:

    "For all the 'behavioral work' that Zeller claims, he may have run across one aspect of breaking habits - that you don't keep doing and using the same stuff, that you 'change' venues and sometimes acquaintances. And while most newbie vapers do want the flavor that is 'just like' the cigarette brand they smoked, and while some connoisseurs really like the NETs, there are many that have to go to other flavors, even candy flavors! or fruit! to get out of the habit. Seems like this would be at least Some part of Zeller's evidently wide range of behavioral studies, but I guess not Why is it that almost everyone here knows this - not that all need it but at least know this to be true of either themselves or other fellow posters and this guy hasn't a clue?"
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    Do any of the pending FDA actions require legislative approval?
    tDCS anyone..?

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    Quote Originally Posted by sonicdsl View Post
    CALL TO PREPARE

    CASAA has issued the first Call to Prepare in CASAA's Action Plan regarding FDA's proposed regulations. This Call to Prepare is your opportunity to begin laying the groundwork for your formal, substantive comment to the FDA. ...
    Thank you for Posting this Sonic.

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    I will most certainly be writing a draft

    I feel, however, that there are some important points left out of CASAA's instructions (or at least not focused on). I would like to ask those more experienced than I at dealing with the FDA since I have been out of the loop for some time, particularly members of CASAA:

    1) Nicotine has been approved for long-term use by the FDA in other forms. While they only approved a few specific products for this, it does show that they don't consider use or long-term use to be very harmful, and by extension it makes no sense to regulate the nicotine out of e-liquid. Should we bring this up?

    - As an added point, there's a lot of hype in the media lately about misuse of liquid leading to poisonings, and this has lead to legislation proposing to ban them. If the FDA uses this excuse, it also does not make sense because nearly every product they approve is dangerous if used incorrectly, and they simply require instructions and warning labels. Should we bring this up as well?

    2) Electronic cigarettes have led to numerous small businesses. Banning them and/or some of their components will undoubtedly lead to a significant loss of businesses and jobs, in a time when decent jobs are scarce. Is this relevant enough to mention?
    Last edited by dragonpuff; 07-18-2014 at 04:44 AM. Reason: Grammar error
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    This Call to Action took a bit more time than the others but as I had a bit of time, I jumped right on it. My draft is written and saved. I'm a bit concerned by the length of the draft at this point...I'm already at a full page. I tried to address all of the points as briefly as possible and re-read it several times with editing in mind. It is just that they touched on so many important bullet points that I don't know that there is anything I can remove until I see more instructions. The best I can hope for is that some poor legislative aide is in a patient mood.
    Last edited by Linden; 07-18-2014 at 04:14 AM.
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    Quote Originally Posted by Cool_Breeze View Post
    Do any of the pending FDA actions require legislative approval?
    If I am not mistaken there are two kinds of approval needed...

    First, the Office of Management and Budget (OMB) will have to approve the final deeming regulations.
    Technically, once approved by OMB the regulations can be published and become effective.

    However, Congress does have an opportunity to stop the deeming regulations if they don't like them.
    They do not have to explicitly approve them though, and if they do nothing then the regulations become effective as written.

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    Quote Originally Posted by Linden View Post
    This Call to Action took a bit more time than the others but as I had a bit of time, I jumped right on it. My draft is written and saved. I'm a bit concerned by the length of the draft at this point...I'm already at a full page. I tried to address all of the points as briefly as possible and re-read it several times with editing in mind. It is just that they touched on so many important bullet points that I don't know that there is anything I can remove until I see more instructions. The best I can hope for is that some poor legislative aide is in a patient mood.
    I'm not sure I'd worry about the length.
    Some of the stuff the "professionals" submit are huge.

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    DC2 - Do you know the process for Congress to take action as you suggest below?

    Quote Originally Posted by DC2 View Post
    If I am not mistaken there are two kinds of approval needed...

    First, the Office of Management and Budget (OMB) will have to approve the final deeming regulations.
    Technically, once approved by OMB the regulations can be published and become effective.

    However, Congress does have an opportunity to stop the deeming regulations if they don't like them.
    They do not have to explicitly approve them though, and if they do nothing then the regulations become effective as written.
    tDCS anyone..?

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    Quote Originally Posted by Cool_Breeze View Post
    DC2 - Do you know the process for Congress to take action as you suggest below?
    No, I do not.

    And unfortunately I can't remember who on this forum was talking us about it.
    And the search function is not of any help in finding out where those discussions were taking place.

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