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

Bill Godshall;10941250 said:

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

On April 25, 2011, the FDA issues statement agreeing to comply with Judge Leon’s ruling and stated the agency’s intent to propose the “deeming” regulation to apply Chapter IX (of the TCA) to e-cigs.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm

In 2011, the FDA issued many documents delineating that tobacco products regulated by Chapter IX that weren't marketed prior to February 15, 2007 must either submit either a Substantial Equivalent (SE)
or New Tobacco Product application and that FDA must approve the application BEFORE the product can be legally marketed in the US (which would ban all e-cigs until they are first approved by FDA)
Substantial Equivalence and New Tobacco Product applications
http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm
Draft Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions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Draft Guidance: Establishing a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007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
http://www.fda.gov/TobaccoProducts/...Evaluation/SubstantialEquivalence/default.htm
Draft Guidance: Applications for Premarket Review of New Tobacco Products
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf

In the fall of 2011, more than 5,000 people signed a 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 testified at a FDA public hearing on Section 918 about the benefits of e-cigs, and how FDA approved drugs didn’t help them quit smoking
http://www.fda.gov/Drugs/NewsEvents/ucm324938.htm
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 submittee 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 the 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

On April 23, 2013, the FDA submitted a Report to Congress per Section 918 that contradicted and misrepresented evidence provided to agency on the health benefits of e-cigarettes at the December 17, 201 Section 918 public hearing, and in public comments submitted to agency's Docket on Section 918 in January 2013.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf

In September 2013, the FDA announced it will give $273 million to many THR opponents and FDA regulatory advocates, to call them Tobacco Centers for Regulatory Science
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368992.htm
http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm369005.htm
http://prevention.nih.gov/tobacco/tcors.aspx
http://www.nih.gov/news/health/sep2013/od-19.htm

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