FDA to send Section 918 report to Congress on Monday (will include e-cigs)

Discussion in 'Legislation News' started by Bill Godshall, Mar 29, 2013.

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  1. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Excerpt from article in today's Wall St. Journal
    Graphic New Antismoking Ads Launched
    Graphic New Antismoking Ads Unveiled - WSJ.com

    Section 918 of the FSPTCA at
    http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf
    FDA is sending Congress a report on Monday.


    It will be interesting to see how badly FDA's report to Congress misrepresents the testimony provided at the FDA's Dec. 17th public hearing and the written testimony submitted by 5,300 vapers in January.
     
  2. junkman

    junkman Ultra Member Verified Member ECF Veteran

    Aug 24, 2012
    Louisville
    A but out topic to Mr. Godshall's discussion, but also from the WSJ article:$48 million to run the ads. 207 thousand additional calls. $232 per caller. 20% claimed quit rate per Dr. Friedan at CSC. So now we are at $1160/quitter. Still not bad if the numbers are to be believed.

    But that is quite a success rate. I wonder how the measure that and what they consider quitting? For a week? A month? Out long term? My guess at that kind of rate, it isn't people who quit for very long.
     
  3. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    FDA's Section 918 report to Congress on Monday is the subject of a April 23rd FDLI conference session

    Agenda
    Interesting panel makeup, as e-cigarette consumers and THR advocates accounted for two thirds of the testifiers at FDA's Dec. 17th hearing, and submitted 99% of the written comments to FDA's docket, while drug companies (and their funding recipients) accounted for about one fourth testifiers at the Dec 17th hearing.
     
  4. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Please note that the E-Cigarette Forum urged consumers to send FDA comments on Section 918 of FSPTCA
    http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html

    5,366 comments were submitted to FDA's docket on Section 918, with vast majority (probably >5,300) from vapers delineating their use and effects of tobacco cigarettes, FDA approved drugs, and e-cigarettes; and urging the agency to not impose unwarranted regulations that would ban or otherwise restrict adult smoker's legal access to e-cigarette products.
    Regulations.gov

    Also please note that the White House still hasn’t responded to January's ECF generated:

    Petition to "Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids."
    https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd


    Below are webcasts of the FDA's Public Hearing on December 17, 2012

    FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence
    FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

    FDA 12/17/12 Hearing: 1 of 4 webcast (FDA's Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA's Elaine Keller 1:00-1:14, SRNT's Jonathan Foulds 1:14-1:47)
    https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal

    FDA 12/17/12 Hearing: 2 of 4 webcase (ATTUD's Michael Steinberg 0.00-0.10, CTFK's Danny McGoldrick 0.11-0.17, ACS' Angela Jones 0.18-0.24, Legacy's David Abrams 0.24-1.10, Smokefree Pennsylvania's Bill Godshall 1:11-1:28, TCLC's Kathleen Dachille 1:28-1:37)
    https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal

    FDA 12/17/12 Hearing: 3 of 4 webcast (ACSH's Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria's James Dillard 0:22-0:37, Johnson & Johnson's James Walmsley 0:38-1:09, GlaxoSmithKline's Howard Marsh 1:09-1:38, What A Smoke's Mark Anton 1:38-1:47)
    https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal

    FDA 12/17/12 Hearing: 4 of 4 webcast (Blue Mist Vaping's Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association's Lou Ritter 0:08-0:32, Legacy's David Abrams 0:33-0:36)
    https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal
     
  5. cashley

    cashley Full Member

    Mar 11, 2013
    round rock,texas
    Thank you for the information and links
     
  6. rockymtnrobin

    rockymtnrobin Super Member Verified Member ECF Veteran

    Aug 18, 2012
    Colorado
    Bill I was one of the 10,000 Vapers who did follow the December 17, 2012 webcast. Looking at the meeting as it stands today I don't see anyone speaking for US.
    Are we being dismissed?
     
  7. tnt56

    tnt56 Vaping Master Verified Member ECF Veteran

    Sorry but I just got a bad gut feeling about all this. Big tobacco has all the money while they tried their best to kill us all.
     
  8. Fiamma

    Fiamma Ultra Member Verified Member ECF Veteran

    Supporting member
    Apr 9, 2012
    So Calif
    I agree with the bad gut feeling, but would amend it with BT and BP have all the money, while BT did it's best to kill us and BP did it's best to keep us on the merry go round, smoke, NRT's, relapse to smoking, NRT's and round and round. Both need to protect their cash cows, now BT moving into E Cigs and BP continuing to fight for their ineffective 'quitting aids' that only create more smoking during relapse periods, and ultimately protect their smoker's disease profits from the meds required to keep smokers alive in extremis.
     
  9. mostlyclassics

    mostlyclassics Ultra Member Verified Member ECF Veteran

    Supporting member
    Bill, thanks for the summaries and the links. Do you know if there's a printout of all 5,300-odd comments? I'd love to buy copies and snail-mail them to my congresscritter and both senators.
     
  10. ElectricalSocket

    ElectricalSocket Super Member Verified Member ECF Veteran

    Jan 20, 2013
    Houston
    Here's the way I see BT vs. BP.

    BT has a lot to GAIN by supporting and selling e-cigs. They sell an addictive product and if they want to jump on the bandwagon, I don't see them having any issues with e-cigs. Their first goal isn't to kill or harm people, it's to cash in on a highly addictive product. E-cigs still fit the bill.

    BP on the other hand....THEY are the ones who benefit from chronic illness. THEY are the ones who want e-cigs to go away. BT sells a harmful product that people choose to start using, BP will sell AIDS infected blood products to innocent hemophiliacs without batting an eye (look up Bayer Aids scandal). I know it's ignorant to generalize, but generally speaking, BP is much worse than BT right now.
     
  11. Fiamma

    Fiamma Ultra Member Verified Member ECF Veteran

    Supporting member
    Apr 9, 2012
    So Calif
    Yes BT has a lot to gain, HOWEVER, they could enormously gain from just the right kind of regulation. If the FDA follows the Blu formula of small cigarette look a like e cigs BT gains as they are moving into just that size market.

    Blu has helped a lot of people quit, but some new vapers move on to something a bit larger and with longer battery life, and some move back to tobacco cigarettes as what they get is not enough to keep them off tobacco.

    The FDA could cement that small size and mandate low nicotine prefilled unrefillable cartridges and decimate the market for anything else, which would probably keep more people smoking and the governments collecting sin taxes on tobacco and keep BP happy with their NRT/relapse/big drug sales down the road current model. They continue on down the road, BT selling BOTH and BP not missing a beat or a buck.

    I see it as not so much BT vs BP but a bonus for both, IF FDA mandates the small low nic model.

    Not every quitter reads ECF, knows what else there is, or takes up vaping for the long term as a hobbyist. We are the minority of e cig users.
     
  12. DaveP

    DaveP PV Master & Musician ECF Veteran

    Supporting member
    May 22, 2010
    Central GA
    Funny, a search for "electronic" only found references to electronic storage and retrieval methods. Nicotine is referred to as a tobacco product and not called out in a separate clause for electronic cigarettes.
     
  13. Petrodus

    Petrodus Vaping Master ECF Veteran

    Oct 12, 2010
    Midwest
    Well said !!
     
  14. Petrodus

    Petrodus Vaping Master ECF Veteran

    Oct 12, 2010
    Midwest
    I would be SHOCKED if the FDA would allow bottled e-liquids with higher nic levels
    and the flavor choices we enjoy today.

    I suggest those who prefer Blu/NJOY cigalikes with low nic levels
    and few choices of flavors ... will not be effected by the FDA regulations.

    Those here who argue our favorite vape machines, nic levels, and flavors
    help smokers switch to e-smoking and save lives ... Keep in mind ...
    The FDA COULDN'T CARE LESS !!
     
  15. DaveP

    DaveP PV Master & Musician ECF Veteran

    Supporting member
    May 22, 2010
    Central GA
  16. brooke2775

    brooke2775 Senior Member ECF Veteran

    Jun 20, 2010
    Mississipi
    not funny, but funny, scared me.
     
  17. Petrodus

    Petrodus Vaping Master ECF Veteran

    Oct 12, 2010
    Midwest
  18. Talyon

    Talyon Vape 4 Life Verified Member ECF Veteran

    Supporting member
    Feb 21, 2013
    Toronto
    Gotta love April,fools,day eh!
     
  19. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Looks like the FDA missed its Congressionally mandated deadlines today for submitting three reports, apparently including the Section 918 report cited in this thread.

    http://www.huffingtonpost.com/huff-wires/20130401/us-fda-nicotine-replacement/?

     
  20. Tintreach

    Tintreach Super Member Verified Member ECF Veteran

    It sounds like a bit more breathing room until they do submit. Interesting, I heard on the news this morning a blurb about the new CDC campaign. Would be cool if they pulled a study group and handed them a decent mod and a bottle of liquid to start and what would the success rates would be?

    I think these forums (and others) are a pretty good testament to how effective vaping is to quitting analogs. However it looks like we don't have any study data to back up the effectiveness of it to offset whatever BS the FDA proposes.
     
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