FDA Deeming Comments - I'm starting to be worried - Page 2
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Thread: FDA Deeming Comments - I'm starting to be worried

  1. #11
    Super Member Verified Member Painter_'s Avatar
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    I have started copying and pasting your one page comments every day. Today I posted #3.
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  2. #12
    PV Master ECF Veteran Jman8's Avatar
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    Quote Originally Posted by DrMA View Post
    I might be completely wrong on this, but wouldn't it be a positive impact if the majority of comments about e-cigs were against the deeming, rather than the other way around?
    I'm not sure how we would ever know this, would be my first response to such a question. My second one would be based on what FDA has said that comments don't equal votes and that one well written comment is worth more than 1000 comments that treat a comment as if this is actually up for some sort of vote.

    Reality is they are going to regulate eCigs as tobacco products because thus far they fully believe they are empowered to do so. And so, a comment saying, "don't regulate this for these are better than smoking" is IMO a waste of a comment. How harsh or tame those regulations are, over the long haul, remains to be seen. Thus far, I see what has been proposed as tame. And haven't yet seen a comment go into detail that shows good reason for why harsh regulations make sense. Yet, I do think harsh regs over the long haul are something that could occur.

    I still think moving the grandfather date, to whenever regs become finalized, is the thing for us consumers to be pushing for. A comment to FDA on this sort of item is likely not to have the desired effect. A campaign from likes of CASAA whereby hundreds, if not thousands (hopefully even millions) of us are writing to congress to move that grandfather date, with reasoning provided, might lead to that desired effect as Congress does get to weigh in before the rules become final.

    But lately, I'm now thinking best way to address what FDA is asking for in its proposal is to say that regs ought not to occur until the scientific studies are concluded AND reviewed by independent scientists AND that data is extrapolated into sensible policies by elected officials. I think making policy/regs before the science is completed works against basic mission of FDA and what they keep saying in hearings when asked what is role of TCP. Furthermore, it would bring into question their credibility if they were to invoke harsh regulations wrt where the data currently stands, and would mean litigation galore would ensue (under best case scenario) or just open door for an underground market that the rational people amongst us could support, knowing they are dealing with a deceptive government.

    And I kinda think FDA is going to wait for the studies to conclude, though not sure if they will allow for independent scientific review and for elected officials to weigh in before they try to invoke certain regulations. IOW, I think FDA is a good 2 years away from Final Rule, but of course, don't quote me on that, as the old adage of "we just don't know" is applicable to FDA response to eCigs, more than it is to actual harm from an eCig.
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  3. #13
    Ultra Member ECF Veteran DrMA's Avatar
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    Default FDA Deeming Comments - I'm starting to be worried

    Very interesting points, Jman. Would you consider rephrasing a little bit and submitting something along those lines as a comment to the FDA?

    Also, I'd encourage you to read Nitzkin's comment posted above. He also presents a different and compelling perspective.
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    The war against vaping continues: http://www.e-cigarette-forum.com/forum/fda-regulations/
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    PV Master ECF Veteran Jman8's Avatar
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    Quote Originally Posted by DrMA View Post
    Very interesting points, Jman. Would you consider rephrasing a little bit and submitting something along those lines as a comment to the FDA?
    Fully intend to do so.
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    My comment:
    The only way I was able to quit smoking conventional tobacco cigarettes was by means of vaping. I have been smoke-free for 8 consecutive months, thanks to e-cigs and the flavors such as cotton candy, creamsicle, and coffee, that keep me, a 53-year-old woman, vaping.

    I had tried just about every other quit method--gum, cold turkey, and even Wellbutrin/buproprion (sp?) -- in the past, all with no long-term success. The only reason I haven't tried Chantix was that I have a medical condition that contraindicates its use.

    E-cigs contain no tobacco and should not be regulated as if they were combustible tobacco products. The vapor from e-liquid contains no smoke, and thus, no significant amounts of the toxic chemicals and cancer-causing agents from smoked tobacco. Even my family doctor notices a vast improvement in my lung functioning.

    Please hold off on imposing e-cig regulations that would be burdensome, cost-prohibitive, and even inappropriate until all the scientifc evidence concerning e-cigs have been conducted. It would be unfair and unjust to consumers and small businesses that make e-cigs to presume harm with insufficient evidence. It would also be unjust to impose burdensome rules based more on moral panic, rash judgment, and ideology that science
    wv2win, dragonpuff, Jman8 and 3 others like this.

    Last TC: 9/12/14

  6. #16
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    My apologies for not responding sooner to this thread. Life has been . . . busy.

    Today, we issued our First Call to Prepare: CASAA: First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment

    We expect to issue 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.

    Our belief is that individualized, responsive, and intelligent comments by consumers will be far more persuasive than multiple comments that are simply copied and pasted. This isn't a vote or a popularity contest . . . it's a process designed to inform the FDA on the topic.

    We appreciate that for many, the thought of reading the proposed regulations and all accompanying documents and then preparing a well thought-out comment in response is daunting (and that's a bit of an understatement). The whole basis for CASAA's Action Plan is to help people prepare thoughtful and responsive comments by giving them a road map (but not a form) and providing guidance on what information is likely to be most helpful and effective.

    Yes, it'd be nice to see hundreds of thousands of comments from vapers . . . but given a choice between quantity and quality, I'd pick quality. Having said that, the guidance we're issuing is just that . . . guidance. People are, obviously, free to do as they wish. But we're hopeful that those who believe that the number of comments is of primary importance will still take the time to read CASAA's guidance and formulate a responsive, personalized comment that won't be dismissed out of hand by the FDA.

    (This is a post copied from the CASAA subforum.)
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  7. #17
    DC2
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    I like the idea of doing both.

  8. #18
    Ultra Member ECF Veteran DrMA's Avatar
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    Quote Originally Posted by DC2 View Post
    I like the idea of doing both.
    That's been my plan from the beginning.

    Thank you, Julie, for sharing your thoughts.
    faile and aikanae1 like this.
    The war against vaping continues: http://www.e-cigarette-forum.com/forum/fda-regulations/
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    Ultra Member ECF Veteran DrMA's Avatar
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    New micro-comment posted
    The war against vaping continues: http://www.e-cigarette-forum.com/forum/fda-regulations/
    Get involved: casaa.org

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    Here is what I posted for my first comment:

    Any regulation regarding e-cigarettes will best serve the public interest if they are protected. E-cigarettes serve as a viable alternative to smoking which is far less hazardous and has already served to help thousands of lifelong smokers abstain from cigarettes. It is crucial to keep this technology user-friendly so people continue to use it instead of going back to cigarettes. Eliminating flavors, severely restricting nicotine amounts, and prohibiting newer, more effective forms of electronic cigarettes all serve to discourage their use; contrary to popular opinion, this will likely lead to people going back to smoking instead of quitting altogether, as many users of this technology were unable to quit previously. Preserving e-cigarette use for adults in its current form is crucial to protecting public health.
    Last edited by dragonpuff; 07-18-2014 at 11:37 AM.
    DC2, NorthOfAtlanta, LaraC and 2 others like this.

    "The very powerful and the very stupid have one thing in common. Instead of altering their views to fit the facts, they alter the facts to fit their views... which can be very uncomfortable if you happen to be one of the facts that needs altering." Doctor Who

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