Not feeling the 'Bern'

Discussion in 'FDA Regulations' started by dimco1, Apr 18, 2017.

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  1. dimco1

    dimco1 Full Member

    Dec 8, 2016
    Hello All -
    I sent letter to VT's representation in Wash. DC last week Re: the support Cole-Bishop bill; This is the response I just received, from one of our Senators in VT. If Bernie Sanders feels this way about the supported studies from FDA, CDC - I now have only small hopes anything will ever change...

    "Thank you for contacting me regarding the FDA Deeming Authority Clarification Act.

    As you know, last year the Food and Drug Administration’s (FDA) passed a rule extending its authority to regulate tobacco products, including vapor products. Under the new rule, FDA will now regulate vapor pens, electronic cigarettes, cigars, hookah pipes, pipe tobacco, and nicotine gels under the Federal Food, Drug and Cosmetic Act. The new rule also regulates youth access to tobacco products and establishes a policy for premarket review of new tobacco products, but includes an exemption for small-scale tobacco product manufacturers. In addition, FDA’s rule requires that tobacco products introduced after February 2007 be subject to a new regulations and approval process. The bill also includes licensing and advertising guidelines for these products.

    The FDA Deeming Authority Clarification Act would exempt products introduced since 2007 from these guidelines so that only new and future products would be subject to the rule.

    I support FDA’s efforts to better regulate the growing array of tobacco products, especially those that are targeted to or used by young Americans. We have long known that tobacco poses a significant public health threat, and the alarming increase in youth tobacco use is cause for concern, especially use by high school students. According to a study supported by FDA and the Centers for Disease Control and Prevention, national youth e-cigarette use increased from 1.5 percent in 2011 to 16 percent in 2015, a 900 percent increase.

    The FDA Deeming Authority Clarification Act is currently being considered by the House Subcommittee on Health, of which I am not a member. Please be assured that I will keep your thoughts in mind should similar legislation be introduced in the United States Senate.


    United States Senator"
    LaraC and Sylvie like this.
  2. Verb

    Verb Ultra Member Verified Member ECF Veteran

    Apr 26, 2014
    Eastern, PA, USA
    What exemption for small scale manufacturers is he referring to? News to me.
    LaraC likes this.
  3. leftyandsparky

    leftyandsparky Ultra Member Verified Member ECF Veteran

    Nov 22, 2015
    Somewhere in the South
    I hate so many people will not read 1 good thing about vaping, and they decided just to follow the leader (FDA) on what they say. You would think he would want a healthier American.
    JustWondering1, Rossum and ChelsB like this.
  4. puffon

    puffon Ultra Member Verified Member ECF Veteran

    Sep 18, 2014
    The Villages, FL
    Premium cigars.
    The ones the politicians smoke.
    JustWondering1, LaraC, Rossum and 2 others like this.
  5. dimco1

    dimco1 Full Member

    Dec 8, 2016
    I just couldn't resist sending this reply to Bernie. I hope it is appropriate and he will consider..?

    Dear Senator Sanders, thank you for your reply and with all my respect - please consider the following for all those you stand for. I don't need to tell you, we live in a complicated world, I only hope this information may round out your opinions and response to this complicated subject. In my opinion (and many, many others) the study you site and the FDA regulations are deeply flawed by special interest. The Surgeon General's report on E-Cigs is an embarrassment to medical science on this subject. However I do agree, minors should not have access to these E-Cig. products.

    Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review

    "Data from the Centers for Disease Control [2013] National Youth Tobacco Survey reported doubling in EC experimentation by 13–18 year old students from 1.1% in 2011 to 2.1% in 2012; however, 90.6% of them were smokers. From the whole population, only 0.5% were nonsmokers experimenting with ECs. Once again, participants were asked about ever experimenting with an EC in the past 30 days, not regular or daily EC use. Recently, a survey of more than 75,000 students in South Korea was published [Lee et al. 2013]. Although they found that 12.6% of them were daily smokers (8.6% were using only tobacco cigarettes and 3.6% were using both tobacco and ECs), only 0.6% of nonsmokers had used ECs in the past 30 days. Although the above mentioned data have been used as arguments to support the fact that a new epidemic of nicotine addiction through the use of ECs is appearing, in reality they are showing that any experimentation with ECs is done by smokers. This is in fact a positive finding, and could lead to reduced smoking prevalence through adoption of EC use. Therefore, ECs could serve as gateway from smoking; on the contrary, there is no evidence indicating that they could be a gateway to smoking. It is promising to see that penetration of EC use in youngsters is virtually nonexistent, especially when you take into consideration that there is currently no official regulation in most countries to prohibit the access to ECs by youngsters."

    Respectfully yours,
  6. Verb

    Verb Ultra Member Verified Member ECF Veteran

    Apr 26, 2014
    Eastern, PA, USA
    But, they were not exempt in the final published rule. There were two rules proposed one that exempted premium cigars and the other did not. The FDA went with the rule that included all cigars in the deeming.
    LaraC and puffon like this.
  7. retired1

    retired1 Administrator Admin Verified Member ECF Veteran

    Supporting member
    Apr 5, 2013
    Rarely, if ever, does the actual politician reply to correspondence from their constituents. The staff flunky's are the ones that do the replies. It's doubtful he even saw it.
    JC Okie, halbgott and LaraC like this.
  8. JustWondering1

    JustWondering1 Ultra Member ECF Veteran

    Aug 29, 2015
    Hopefully, the staff keeps track of what his or her constituents want even if they don't see the correspondence.
  9. retired1

    retired1 Administrator Admin Verified Member ECF Veteran

    Supporting member
    Apr 5, 2013
    It's possible I guess. However, the cynic in me has a pretty low opinion of any politician, and an even lower opinion of staff lackey's. He and his campaign staff were repeatedly asked about his stance on e-cigarettes during the elections and he nor his staff responded to any of those questions.

    That tells me that he either doesn't care, or he fully agrees with the FDA.

    And re-reading the response in the original post, it appears he DOES agree with the FDA's classification of e-cigarettes as a tobacco product. Just another clueless politician.
    LaraC and JustWondering1 like this.
  10. JustWondering1

    JustWondering1 Ultra Member ECF Veteran

    Aug 29, 2015
    I think you are right about this, Bernie's going to stick with the party line on this. It's a shame!! The pols get rich by pandering to their special interests, and the public gets the raw deal!
    LaraC likes this.
  11. go_player

    go_player Senior Member ECF Veteran

    Mar 2, 2012
    I first met Bernie more than 30 years ago, and met him quite a number of times back then. I don't know him well but some close family friends were in his inner circle back when he was just Mayor of a small city. I know his core constituency quite well.

    That reply doesn't surprise me much. It's very much in line with that constituency's rather sniffy view of the world. Tbh, I think vaping has a lot more to fear from New England Progressives than it does from Big Tobacco.

    That said, Bernie is a bit of an odd duck. I'm reminded of this on the not infrequent occasions when he sounds very much like Donald Trump in ways that, if his constituency were at all consistent, would require them to cast him into outer darkness. They don't of course, because our politics is more a team sport than anything else these days, and he's their guy.

    The thing about Bernie is that, while I don't particularly like his politics, he really isn't a run-of-the-mill politician. Once he gets a hair up his nethers about something he'll follow that hair where it takes him (which is more often than not about where you'd expect.) Given his politics and his constituency that response is the response I'd expect, but I could actually see him being amenable to reason on this subject, and he'd be dogged about it once convinced.
    Mowgli likes this.

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