CASAA Call to Prepare re FDA Regulations Comments

Discussion in 'FDA Regulations' started by sonicdsl, Jul 17, 2014.

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  1. sonicdsl

    sonicdsl Reviewers Mgr
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    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
     
  2. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    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:

    http://www.e-cigarette-forum.com/fo...cco-products-biggest-ally-5.html#post13220617

    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 :facepalm: 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?"
     
  3. Cool_Breeze

    Cool_Breeze Vaping Master Verified Member ECF Veteran

    Do any of the pending FDA actions require legislative approval?
     
  4. zoiDman

    zoiDman My -0^10 = Nothing at All ECF Veteran

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    Thank you for Posting this Sonic.

    Already Starting to Forward Links to me Non ECF Member Friends and Contacts.
     
  5. dragonpuff

    dragonpuff Ultra Member Verified Member ECF Veteran

    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?
     
  6. Linden

    Linden Super Member ECF Veteran

    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.
     
  7. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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    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.
     
  8. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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    I'm not sure I'd worry about the length.
    Some of the stuff the "professionals" submit are huge.
    :)
     
  9. Cool_Breeze

    Cool_Breeze Vaping Master Verified Member ECF Veteran

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

     
  10. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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    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.
    :(
     
  11. Cool_Breeze

    Cool_Breeze Vaping Master Verified Member ECF Veteran

    A wild guess on my part would suggest it wouldn't involve legislation since isn't law-making per se.

     
  12. SeniorBoy

    SeniorBoy VapeFight.com Founder Verified Member ECF Veteran

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    With respect to legislative approval and here I'm referring to steps eight and nine with sources below.

    After OMB which is step 8 it's still not the law of the land. The FDA MUST submit to GAO and Congress under:

    Congressional Review Act
    Chapter 8 - CONGRESSIONAL REVIEW OF AGENCY RULEMAKING
    (5 U.S.C. 801-808)

    Section 802 is Congressional disapproval procedure.

    Sources for your reading pleasure:

    http://www.cspnet.com/category-news...lemaking-process-and-fda-tobacco-deeming-regs

    5 U.S. Code Chapter 8 - CONGRESSIONAL REVIEW OF AGENCY RULEMAKING | LII / Legal Information Institute

    Of course, I'm not an attorney or K street shill so that's just my reading of the procedures.

    :)
     
  13. Jman8

    Jman8 Vaping Master ECF Veteran

    CASAA Call To Prepare with emphasis on black market and flavors makes for a happy Jman.

    Though I do hope a further Call To Prepare will help arm us with scientific studies that ought to be cited to make certain things known and to counter the "we just don't know" rhetoric. Not sure if thousands of us need to link to the same 10 or so studies, but feel at least some of us ought to be presenting that data and its relevance to what is written in the regulation proposal.
     
  14. zoiDman

    zoiDman My -0^10 = Nothing at All ECF Veteran

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  15. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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    I always link to at least one thing (if not multiple) when making comments.
     
  16. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

    This came up in the Economic Impact Analysis thread. From the 'impact doc':

    "We note that not all of these regulatory alternatives are necessarily legally permissible."

    From the 'deeming doc':

    "We do not believe that we have
    the authority to alter or amend this
    grandfathering date, which is set by
    statute."

    So it was assumed that only Congress could change the gf date. However, the FDA has requested a change in grandfather date on other occasions, but it needed an amendment to the statute. (Fitzie brought this up in the impact thread).

    http://www.fdli.org/docs/default-document-library/wilcox.pdf?sfvrsn=0

    See page 9. And here's one of the references:

    http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM280094.pdf

    Also in the "Legacy seminar":

    One-on-One with Mitch Zeller, Director of the FDA Center for Tobacco Products

    ... there is mention of the grandfather date - how Congress created it, and while Zeller doesn't state who exactly could alter it, both the deeming and impact docs requests comments about it. The specific area of that is around 59 minutes into the recording. And he 'appears' to be sincere about this. I don't know IF he is, but if you're the type of person that would take a person at his word, or one that would throw one's words back at them :) ... you might go back to around 42 minutes into the recording and listen (relisten) to what he has to say. There is much fodder there for comments, imo. Plus it shows his thinking well... on how he advocates ecigs for the hardcore smokers but how he has 'concerns' about how the 'greater number of smokers' who may want to quit and how dual use (plus 'initiation' by teens) would be bad for public health. He even 'gives' that those who dual use may go on to quit. Something we didn't hear in the Senate HELP hearing.

    He 'sounds' as if he could be convinced to allow ecigs to be continued to be sold and used, however, all the other stuff we know from what he has said elsewhere, and how the FDA has acted (in 2009, eg.) tends to conflict with how he 'sounds' here. And actions speak louder than words. That said - it would be wrong, imo, for some not to mention these things (quote him perhaps) in their comments.
     
  17. crxess

    crxess ECF Guru Verified Member ECF Veteran

    FDA POT/KETTLE the all in one double edged sword of Government.

    Reading the below link, I get the Idea the FDA finds it logical to use Nicotine LONG TERM as a cessation tool to prevent return to Cigarettes for ex-smokers. Yet they don't want us to because....................why? :blink:

    Long-term Nicotine Replacement Therapy: Cancer Risk in Context

    *should mention, I'm working on my testimony also.:)
     
  18. SeniorBoy

    SeniorBoy VapeFight.com Founder Verified Member ECF Veteran

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    Just found an interesting source with respect to my previous post in this thread about the Chapter 8 - CONGRESSIONAL REVIEW OF AGENCY RULEMAKING. Certainly adds some context as we rub our crystal balls. /lol

    "Examples of joint resolutions[edit]

    Joint resolutions of disapproval have included:

    S.J.Res. 6, 107th Congress (2001), providing for congressional disapproval of the rule submitted by the Department of Labor relating to ergonomics (became Pub.L. 107–5 on March 20, 2001);
    S.J.Res. 17, 108th Congress (2003), disapproving the rule submitted by the Federal Communications Commission with respect to broadcast media ownership (passed Senate 55-40 on September 16, 2003; not acted on by the House);
    S.J.Res. 4, 109th Congress (2005), providing for congressional disapproval of the rule submitted by the Department of Agriculture relating to risk zones for introduction of bovine spongiform encephalopathy (passed Senate 52-46 on March 3, 2005; not acted on by House);
    S.J.Res. 20, 109th Congress (2005), disapproving a rule promulgated by the Administrator of the Environmental Protection Agency to delist coal and oil-direct utility units from the source category list under the Clean Air Act (failed in Senate 47-51 on September 13, 2005);
    S.J.Res. 30, 111th Congress (2010), disapproval of the rule submitted by the National Mediation Board relating to representation election procedures (motion to proceed not agreed to in the Senate 43-56 on September 23, 2010);
    S.J.Res. 39, 111th Congress (2010), providing for congressional disapproval of the rule relating to status as a grandfathered health plan under the Patient Protection and Affordable Care Act (motion to proceed not agreed to in the Senate 40-59 on September 29, 2010). "

    SOURCE: Congressional Review Act - Wikipedia, the free encyclopedia
     
  19. DC2

    DC2 Tootie Puffer Verified Member ECF Veteran

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  20. bigdancehawk

    bigdancehawk Super Member Verified Member ECF Veteran

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    I feel rather pessimistic about the prospect of getting through their thick skulls. Nevertheless, here's what I wrote. I'm mad at them, so please tell me if it's too harsh.

    Thank you for taking the time to read this. I am just a private citizen and consumer. I have absolutely no direct or indirect financial stake or interest in tobacco products, e-cigarette products, pharmaceutical products, or in any of the companies that make and sell them, nor do I have a stake in any public health organization or in any organization advocating or promoting e-cigarettes.

    I’m 67. I started smoking at age 16, worked up to at least a pack of cigarettes per day, often more, and smoked almost every day for 50 years, thus exposing myself, my family and others around me to a host of harmful substances. I’m a fairly successful attorney, former Army medic and former varsity track athlete. I like to think of myself as intelligent, but I could not break the smoking habit. Incidentally, the editor-in-chief of my law school's law review, a highly intelligent person, smoked as long as I did and now suffers from severe emphysema.

    My father, a wonderful, kind and brilliant man but a lifelong smoker, died a horrible death from lung cancer, left my mother a widow, and never got to meet his granddaughter. I knew what was in store for me if I continued on the same path and so I tried quitting many times: cold turkey, nicotine patches, counseling, nicotine gum, hypnotism, drugs, inspirational books, etc. None of these worked and so I continued to smoke, fully anticipating that it would probably kill me sooner or later. And then along came e-cigarettes. They proved to be the only answer for me. Others may succeed with other methods and I applaud them.

    I started out with an e-liquid with a strong nicotine concentration of 36 mg/ml and I've been able to gradually reduce that over time. I haven't smoked a single cigarette in three years. My wife and daughter are happy about that. My doctor says my overall health has greatly improved and he is now recommending e-cigarettes to his patients who smoke.

    I don't miss smoking at all. I feel better than I have in years, energized, and I breathe freely. I no longer cough, I have better stamina, better lung capacity, I can exercise, I no longer dread emphysema, my clothes don't smell of cigarettes, there are no cigarette butts and ashtrays in my house, and I can "vape" in some public places rather than leaving my wife alone, venturing out in inclement weather, shivering in the cold, feeling like an outcast, and inhaling second hand smoke. Bans on vaping in public places threaten to force me right back outside with the smokers. I quit smoking and it seems I’m still demonized as major threat to public health. Yet, there is no credible evidence that I pose a threat to anyone. Of course, I fully realize that evidence has little to do with it. Children might get the idea that it’s “cool” at the mere sight of an old man vaping. Or it might “re-normalize” smoking. Gosh, it might even inspire vampires to attack us in the night!

    I found that the little things sold in convenience stores, gas stations and kiosks that try to look like cigarettes are unsatisfactory. These are clumsy, primitive, costly devices. I tried them and quickly reverted to smoking cigarettes. Many of these products are manufactured and sold by big tobacco companies. But, thanks to small, innovative manufacturers competing for business, the second and third generation products are vastly better and have made it possible for me to quit smoking for good. It is wrong for you to call them "tobacco companies."

    I would never consider going back to smoking, but I am afraid there are powerful forces promoting junk science and ill-informed knee-jerk zealots at work who would like to see these innovative products and the small companies that produce and sell them regulated into oblivion. The costs of applying for approval will simply be too great for them. Some of the statements now being made to justify draconian regulation are astonishingly ignorant, unscientific, or outright lies. If the situation doesn't change, there will be millions of cigarette smokers who will lose out on a great opportunity to prolong their lives.

    If these innovative products can no longer be sold legally, they or others like them will be sold illegally and they will probably be just as easy to get as alcoholic beverages during Prohibition. I'm sure I'll have no problem getting them. Of course, there will be no way to know who made them or whether they have been made with contaminated or dangerous ingredients.

    I fear that the FDA will promulgate regulations based on bad science performed by biased researchers. For example, I note that the FDA is funding research on e-cigarettes and one of the beneficiaries of that funding is one Dr. Adam Goldstein. He is the same person who said this: "It [e-cigarette vapor] could be several thousand degrees when it hits your lungs." Doctor: E-cigarettes don't help smokers kick habit :: WRAL.com (They don’t seem able to spell cigarettes on that site). Dr. Goldstein was given an opportunity to retract that statement or to claim he was misquoted. He has not done so.

    I would think that a third grader, much less somebody with a doctorate degree, knows that any substance hitting human lungs at temperatures approaching several thousand degrees would instantly incinerate them. Where are all the the reports of users suffering significant harm, much less killed, by e-cigarettes? In the same article he is quoted as saying that e-cigarettes are of no use whatsoever in helping people quit smoking. I personally know that is false, and millions of others know it is false. I have no idea what motivates him, but perhaps it has something to do with the fact that he receives substantial funding from Pfizer. Or maybe he just can’t admit he was ever wrong about anything. Statements of this kind reflect unscientific bias and, in my opinion, disqualify Dr. Goldstein from conducting any sort of study of e-cigarettes with our tax dollars. Why do you choose people like this? How do you screen them? Are they your pals? I have worked very hard for the money I pay in taxes and I am getting the awful feeling that you are using it to hire biased people to attack me.

    Thank you again for your attention to this important issue.
     
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