Bill Godshall urges opposition to FDA deeming reg at FDLI conference because it would give e-cig industry to Big Tobacco - Page 3
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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. #21
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    Quote Originally Posted by jimbill View Post
    Good job bill thank you for the good work you have done for this community
    You took the words right out of my mouth.

    Bill, love 'ya man
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    Ultra Member Supporting Member Roger_Lafayette's Avatar
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    As always Bill, your command of the facts, the history, and the English language is beyond stellar.

    I have a couple Qs:

    1) Given that the FDA is undoubtedly hell-bent on getting this rule into place, would it be correct to say that the only two formal mechanisms for preventing that result are rejection of the final draft of the proposed rule (i.e. after the comment period, etc.) by OMB or the: Congressional Review Act - Wikipedia, the free encyclopedia ?

    2) If neither of those methods work, then only aggrieved parties (with standing to sue) can challenge the rule's application in specific cases, I believe?

    For ex., I don't think I could sue the FDA merely because they refused to allow Vision to market a spinner, on the grounds that I like using them. Vision would have to do that. And that's even assuming that Vision was willing to apply to the FDA w/i the 2-year window. If they didn't, then FDA could pull Vision spinners out of the product stream once the window was closed - and Vision would have no recourse. (This example fails if spinners were available prior to Feb '07, but let's just assume that they weren't for purposes of discussion.)
    Don't WAIT until the FDA takes away your right to vape! Join CASAA: a vaper's rights industry-UNaffiliated CHARITY w/ NO PAID STAFF, that has stopped bans on sales of vaping supplies & much more. Join FREE, info. is confidential: http://www.casaa.org/Become_a_Member.html

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    Thank you Bill, you're command of the spoken and written word is always impressive.

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    This is the best thing i have read all day, hell... all year! Thank you very much for this, we all need to stick together and fight this!

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    Quote Originally Posted by glasseye View Post
    Thank you Bill, that was thrilling to read. I hope they felt it when you slapped them with your words. May I have your permission to copy this and send it along with my letters to SC Senate and Representatives?
    That was my thought as well as duplicating it in social media. It would then get read not only by vapors and smokers, but non-smokers as well.
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    I pulled this comment from a Reuter's article yesterday and was a bit confused by it:
    Mitch Zeller, head of the FDA's tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the "substantial equivalence" pathway is even valid for e-cigarettes.

    If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.
    A higher hurdle?
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    Thanks again for the many kudos.

    rothenbj wrote:
    I can only assume the reaction you got from the audience on your very upfront and honest presentation.
    Interestingly, most of the approximately 75 folks in the audience at Tuesday's FDLI conference were lawyers and FDA regulatory compliance staff for tobacco companies, and most of them strongly agreed with my presentation (and many told me so, although they'll never publicly criticize the FDA deeming reg for benefiting their tobacco company at the expense of many small competitors).

    aikanea1 posted the following from a news article
    Mitch Zeller, head of the FDA's tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the "substantial equivalence" pathway is even valid for e-cigarettes.

    If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.
    In order to submit an SE application, the applicant will have to obtain and conduct lots of laboratory tests on a nearly identical product from 2007. But none of the 2014 cigalikes are similar to 2007 cigalikes, and I'd be shocked if anyone has batch samples of e-liquid products that were manufactured and marketed in 2007 (to conduct lab tests on to demonstrate they are nearly identical to e-liquid products now on the market). Thus, it is unlikely any SE applications will be approved, or even submitted, for e-cig products. That's why the deeming reg will ban all e-cig products (or >99% of them) if/when the premarket approval is imposed two years after the Final Rule is issued.

    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), 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).

    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.

    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.

    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 OSHA proposed a federal regulation to ban smoking in most US workplaces back in 1994. After a million comments were submitted to the agency pro and con, OSHA never issued a Final Rule for that proposed regulation, but still hasn't said so publicly (even though that occurred 20 years ago), as government agencies almost never publicly admit that they screwed up.
    Last edited by Bill Godshall; 04-25-2014 at 09:24 PM.
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    Thank you for being so proficient in the language of legislation and vaping and all that it encompasses. I can't even begin to tell you how much your involvement means and a mere thank you does not suffice yet that is all I can offer you with my most humblest and sincerest words.
    Last edited by DetraMental; 04-25-2014 at 09:01 PM.
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    I just submitted Bill's words at:

    Regulations.gov

    They are way too long for the "comments" section but I created an MS-Word document and chose "upload file" and it works that way.

    Thanks Bill,

    Norman
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