Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big Tobacco

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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    Action Alert: Urge US Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big tobacco

    Situation:

    The FDA has stated its intent to propose (by the end of October) the “deeming” regulation to apply Chapter IX of the 2009 tobacco Control Act (TCA) to all e-cigarettes (e-cigs), and to propose additional regulations for e-cigs.

    But Chapter 910 of the TCA would ban all e-cigs currently on the market, Chapter 911 would prohibit e-cig companies from truthfully claiming the products are “smokefree” or are less hazardous than cigarettes, and the rest of Chapter IX and other likely e-cig regulations would give the entire e-cig industry to Big tobacco (and perhaps several large companies that market “Cigalikes”).
    Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act (Passed Congress/Enrolled Bill version) - GovTrack.us

    Please contact your members of Congress:

    To find/contact your US Representative, go to The United States House of Representatives · House.gov and enter your zip code in Find Your Representative (upper right corner) and hit GO, then click on the name of your Representative (beside his/her photo).

    To find/contact your two US Senators, go to U.S. Senate and enter your state in Find Your Senators (upper right corner) and hit GO, then click on the Name or Contact links for your Senators.

    Calls, letters on Congressional websites, faxed letters, and visits to Congress members and/or staff are all recommended. Note that due to the Federal Government shutdown, some Congressional offices and/or contact methods may not be available, so try other offices and/or contact methods.

    Please inform your members of Congress that:

    - e-cigs have helped you quit smoking and/or reduce cigarette consumption,

    - the “deeming” regulation would ban all e-cigs currently on the market per Section 910,

    - FDA already unlawfully banned e-cigs in 2009 until federal judges struck it down in 2010,

    - FDA has made false and misleading fear mongering claims about e-cigs since 2009,

    - the “deeming” regulation would give the entire e-cig industry to Big Tobacco (and perhaps a few large e-cig companies) even if the FDA exempts e-cigs from Section 910,

    - virtually all e-cigs are consumed by smokers and ex-smokers who switched to e-cigs,

    - the CDC has falsely claimed e-cigs are addicting youth and are gateways to cigarettes,

    - States (not FDA) should ban e-cig sales to minors and 25 states already have done so,

    - Section 911 of the TCA would prohibit companies from truthfully saying that e-cigs “emit no smoke” and are less hazardous alternatives to cigarettes,

    - additional FDA regulations for e-cigs (e.g. sales/marketing restrictions, nicotine restrictions, flavoring restrictions, e-liquid sales ban) could deny you and other consumers of legal and/or affordable access to e-cig products you now consume.

    (please note this ECF posting and thread were accidentally deleted last week)
     

    Bill Godshall

    Executive Director<br/> Smokefree Pennsylvania
    ECF Veteran
    Apr 2, 2009
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      Background on FDA and e-cigarettes

      On April 13, 2009, FDA’s Rita Chappelle reveals agency’s policy to deceive public about e-cigs “We don’t want the public to perceive them as a safer alternative to cigarettes.”
      E-Cigarettes Under Fire

      2009 Family Smoking Prevention and Tobacco Control Act (TCA)
      Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act (Passed Congress/Enrolled Bill version) - GovTrack.us

      FDA’s July 22, 2009 press conference and documents misrepresented the evidence about e-cigs to confuse and scare the public, and to help the agency prevail in lawsuits filed by two e-cig companies (Smoking Everywhere and Sottera, Inc. aka NJOY) FDA and Public Health Experts Warn About Electronic Cigarettes
      FDA Warns of Health Risks Posed by E-Cigarettes
      Concerns Voiced by the Public Health Experts About Electronic Cigarettes
      http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
      http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

      On January 15, 2010, Federal Judge Richard Leon strikes down FDA’s e-cig ban as unlawful
      https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54
      https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-55

      In 2011, the FDA issued many documents on Substantial Equivalence and New Tobacco Product applications delineating how tobacco products (regulated by Chapter IX) not on the market prior to February 15, 2007 cannot be legally marketed without prior FDA approval.
      Substantial Equivalence and New Tobacco Product applications
      Tobacco Product Marketing Orders
      Draft Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
      http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM271239.pdf
      Draft Guidance: Establishing a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
      http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM334750.pdf
      Exemption from Substantial Equivalence
      http://www.gpo.gov/fdsys/pkg/FR-2011-07-05/pdf/2011-16766.pdf
      New Tobacco Product Review and Evaluation
      Substantial Equivalence
      Draft Guidance: Applications for Premarket Review of New Tobacco Products
      http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf

      More than 5,000 people signed a 2011 Petition to the White House to “Recognize electronic cigarettes as an effective alternative to smoking and support job creation in this new industry”
      https://wwws.whitehouse.gov/petitio...gov&utm_medium=shorturl&utm_campaign=shorturl

      In response to the 2011 White House Petition, FDA’s then Director of the Center for Tobacco Products Lawrence Deyton responded by claiming:

      “E-cigarette may contain ingredients that are known to be toxic to humans or otherwise harm public health – for example, if they are attractive to young people and lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death. Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemical are found in these products, or how much nicotine people inhale when they use these products.”

      On December 17, 2012, more than a dozen e-cig consumers and supporters testify at a FDA public hearing about the many benefits of e-cigs, and how FDA approved drugs didn’t help them quit smoking
      FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
      https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal
      https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal
      https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal
      https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal

      In January 2013, e-cig consumers submitted more than 5,200 comments to the FDA’s Docket on Section 918 (accounting for >99% of docket submissions) informing the agency of the benefits of e-cigs, and urging the agency to not ban or unjustifiably regulate the products. But the FDA has only made 99 of these comments available to the public
      Regulations.gov
      http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html

      In February 2013, more than 25,000 people submitted a Petition to White House to "Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids", but the White House still hasn’t responded.
      https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd

      4/23/13 FDA Report to Congress per Section 918 of TCA contradicts and misrepresents evidence provided to agency on health benefits for smokers who switch to e-cigarettes or smokefree tobacco products, and on NRT’s dismal success rate for smoking and nicotine cessation at 2/3/11 IOM MRTP meeting, 8/25/11 MRTP meeting, 12/17/12 Section 918 public hearing, and in public comments submitted to agency’s respective dockets.
      http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

      FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
      Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
      http://www.e-cigarette-forum.com/fo...ds-studies-reduced-risk-tobacco-products.html

      In September 2013, the FDA announces it will give $273 million to many THR opponents and FDA regulation supporters, to call them Tobacco Centers for Regulatory Science
      FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
      Tobacco Centers of Regulatory Science (TCORS)
      Centers Research Portfolio
      FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
       

      Oliver

      ECF Founder, formerly SmokeyJoe
      Admin
      Verified Member
        Please be aware - this is a reposted thread: the previous (more or less identical) thread was accidentally removed.

        I'd also like to underscore the importance of this post. The next few months are going to be completely decisive in the future of vaping, and anyone who wishes to keep their access to these extraordinary products should take action.

        In Europe, this battle is currently being won by vapers who have been consistently contacting their elected representatives with their stories, with the evidence, and with the ethical point that it is their right to choose to use these products.

        I'm certain the same will happen in the United States, but only if every vaper takes a few moments to contact their representatives, in their own words, and correct the vast amount of misinformation that has been peddled over the last 5 years.

        Please also note that this thread is going to be heavily moderated to ensure that it does not go off topic.
         

        LTomk

        Full Member
        Feb 28, 2014
        21
        12
        Michigan
          I called my Rep, Mike Rogers, here in Michigan this morning and gave my opinion and how I wanted him to vote on any legislation involving Ecigs. Gave the secretary a quick run down on how it helped me quit and some scientific info on nicotine. Maybe to much info but I feel strongly about this. Please, everybody, get involved. Don't depend on the other guy to do all the leg work. Let's stick together and show them our community strengths. :)
           

          JimmyLee

          Senior Member
          ECF Veteran
          • Deleted by sonicdsl
          • Reason: Please do not cross post - this is already in the Legislative Forum

          Bill Godshall

          Executive Director<br/> Smokefree Pennsylvania
          ECF Veteran
          Apr 2, 2009
          5,171
          13,279
          65
            Here's yet another reason why vapers should urge their members of Congress to oppose the FDA deeming regulation (which would once again ban all e-cigs).

            Durbin/Waxman step up lobbying for FDA deeming reg (that would ban all e-cigs) with staff report falsely accusing e-cig companies of target marketing to youth and falsely claiming e-cigs are addicting youth (as 99% of e-cigs have been consumed by adult smokers and vapers who quit smoking by switching, the vast majority of youth e-cig users are cigarette smokers, and there’s no evidence e-cigs have created daily dependence in any nonsmoker)
            http://www.durbin.senate.gov/public...?File_id=81d14ff7-f2f6-4856-af9d-c20c0b138f8f


            News media sensationalize false fear mongering claims about e-cigs and children by Durbin/Waxman without fact checking
            E-cigarette makers are targeting minors, hooking them on nicotine, say congressional Democrats - NY Daily News
            Are e-cigarettes a gateway drug for children? - MarketWatch
            http://www.nytimes.com/2014/04/15/h...argeting-youth-congressional-report-says.html
             

            badwolf91

            Senior Member
            ECF Veteran
            Mar 13, 2014
            117
            106
            Iowa
              that is such garbage, its not like adults do not enjoy something with flavor in it... I have messaged my representative in hopes he will see. Alcohol continues to have many flavorings this does not make youth flock to it. If the youth wants a drink they will get a drink regardless, the same is with cigarettes. Absolutely no cigarette or ecigarette store I have ever seen markets to youths they all require ID's to enter even. Anyone under 18 normally does not have a card or the ability to buy online so this argument is just hogwash. Why cant a grown man have something with a fruit flavor that they enjoy?

              edit: also contacted my senators. please do the same everybody flood them this is on a national level and get your state guys and give them some of the truth so they are not so easily mislead..hopefully.
               
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              Berylanna

              Ultra Member
              ECF Veteran
              Verified Member
                I got the document from the Federal Register (or something) and converted it to .mobi format which also works on Kindle. I put it in the "files" tab in the We Are CASAA fb page. HOWEVER, I'm not sure I got it ALL, because this appears, at least in pdf format, to be a lot shorter than the rumored 241 pages. OTOH, it is 2 columns in the PDF (NOT in the .mobi) so maybe it depends on font etc.

                So, I don't know how far I'll get how fast, but at this point I can at least read it "on the go" and in line to buy groceries etc, so that when the CASAA CTA comes out maybe I'll have some thoughts in my head.

                Here is the link:

                https://www.facebook.com/download/236210883239135/Deeming-2014-09491.mobi
                 
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