Bill Godshall urges opposition to FDA deeming reg at FDLI conference because it would give e-cig industry to Big Tobacco - Page 4
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Thread: Bill Godshall urges opposition to FDA deeming reg at FDLI conference because it would give e-cig industry to Big Tobacco

  1. #31
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    Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

    So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

    Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).

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    Quote Originally Posted by Bill Godshall View Post
    Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

    So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

    Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).
    Is that a comedic straight-line or what?

    Just begging for ...


    Btw - thank you Bill! That's for all the passion and commitment you bring to clear, sensible thinking on the issues we all value so much!!
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  3. #33
    Ultra Member Supporting Member Roger_Lafayette's Avatar
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    Thanks for your reply, BIll.

    I do want to be sure that I understand the process, so please tell me if I correctly discern the thinking behind your answers.

    Quote Originally Posted by Bill Godshall View Post
    [...] but if the FDA doesn't issue a Final Rule within 32 months (i.e. December 2016), it is unlikely to do so if a Republican wins the 2016 election (but could do so after 2016 if Hillary or another Dem is elected president).
    Q1) And you are saying this because a Dem Pres' OMB is more likely to approve any Final FDA Rule, and/or a Dem Pres is more likely to veto any congressional disapproval under the Congressional Review act, right?

    Quote Originally Posted by Bill Godshall View Post
    Also, if Republicans take over the US Senate later this year, the chances of Obama's FDA issuing a Final Rule on the deeming reg (and many other regs proposed by Obama agencies) will greatly diminish.
    Q2) You are saying this because of the potential for congressional action under the Congressional Review Act, correct?

    Quote Originally Posted by Bill Godshall View Post
    If Obama's FDA issues a Final Rule on the deeming reg (before Obama leaves office), then litigation is the only way to stop the deeming reg from becoming implemented.
    Q3) And this is because Obama could (probably successfully) veto any congressional disapproval under the Cong. Review Act - regardless of what happens this Nov?

    Q4) And that in turn means that there are only three ways to prevent the final rule from resulting in the kind of devastation to that we all fear - namely litigation (possible), legislation that changes the FDA's authority (very unlikely), or (c) unanticipated behavior on the FDA's part (also extremely unlikely)?

    ***

    (Let me switch gears to strategy, and see if you'd be so kind as to let us pick your brain on this one ...)

    Quote Originally Posted by Bill Godshall View Post
    [...] Per Roger's inquiry about the process, it is unlikely that the FDA will issue a Final Rule for the deeming reg for at least two years (as that's how long it takes nearly all other new federal regs) [...]
    If Obama's FDA decides (or is instructed by Obama administration) to not issue a Final Rule for the deeming reg, they'll never say so publicly, and nobody will know for sure (even after Obama leaves office in December 2016). I remember when US OSHA proposed a federal regulation to ban smoking in most US workplaces back in 1994. After a million comments were submitted to the agency, OSHA never issued a Final Rule for that proposed regulation, but still hasn't said so publicly (even though that occurred 20 years ago).
    It's good to know that we have some time. It sounds as if we also may have an opportunity to make harder for the FDA to move quickly?
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    Quote Originally Posted by Bill Godshall View Post
    Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

    So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

    Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).
    Sorry to have "jumped the gun."

    Thanks for all you do,

    Norman

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    Thanks for this,
    Vaping has been my love and passion and has been for a few years now. Makes me happy to read this kinda stuff. We will get through this tooth and nail.

    )O(Speak Ye Little)O(

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    bill, We are extremely lucky to have you on our side. We fully support your approach and are ready to come together as a community behind your lead. Thank you for all that you do for us.

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    Per Roger's questions,

    The FDA and other e-cig prohibitionists chief goal will be to get FDA to issue the Final Rule while Obama is still in office (as many/most newly elected presidents push their own regulatory agenda, and often scrap those of the preceding administration).

    So our key goal must be to prevent the FDA from issuing a Final Rule while Obama is in office. The best tactic to delay the regulatory process is to request more than 75 days to submit public comments (especially since it took dozens of FDA staff and lawyers nearly three years to write the complex 241 page proposal).

    If Republicans win control of the US Senate in November, the Obama administration will sharply scale back its huge regulatory agenda (which will significantly increase our chances of preventing Obama's FDA from issuing the Final Rule), as Durbin, Brown, Blumenthal, Boxer, Markey, Merkley will lose control and much of their influence (to lobby for the FDA deeming reg, increase e-cig taxes, and ban e-cig advertising).
    Kent C, rothenbj, Katya and 11 others like this.

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    Just tie this deeming reg to Obama care somehow and the republicans will fight It to their deathbeds

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    Quote Originally Posted by Bill Godshall View Post
    Per Roger's questions,

    The FDA and other e-cig prohibitionists chief goal will be to get FDA to issue the Final Rule while Obama is still in office (as many/most newly elected presidents push their own regulatory agenda, and often scrap those of the preceding administration).

    So our key goal must be to prevent the FDA from issuing a Final Rule while Obama is in office. The best tactic to delay the regulatory process is to request more than 75 days to submit public comments (especially since it took dozens of FDA staff and lawyers nearly three years to write the complex 241 page proposal).

    If Republicans win control of the US Senate in November, the Obama administration will sharply scale back its huge regulatory agenda (which will significantly increase our chances of preventing Obama's FDA from issuing the Final Rule), as Durbin, Brown, Blumenthal, Boxer, Markey, Merkley will lose control and much of their influence (to lobby for the FDA deeming reg, increase e-cig taxes, and ban e-cig advertising).
    Would adding a request for extension in time to analyze the document due to its length and complexity to all our emails and contact with various governmental agencies as we work through the list of making our feelings bout this thing known be of any help in getting that extension?

    In other words I enough of us ask in a reasonable and rational way for more time help? I am thinking if congresspeople and the FDA hear the request from enough constituents it will carry some weight. Maybe we need to add it to our talking points on all fronts of this fight.
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    Thanks Bill.


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