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Urge Congress to prevent the FDA from banning......

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Urge Congress to prevent the FDA from banning......

Postby Artist Boy » Thu Oct 10, 2013 10:38 am

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

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 e-cig companies).

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.

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.”
http://www.webmd.com/smoking-cessation/ ... 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)
http://www.govtrack.us/congress/bills/111/hr1256/text

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 http://www.fda.gov/NewsEvents/Newsroom/ ... 173222.htm
FDA Warns of Health Risks Posed by E-Cigarettes
http://www.fda.gov/ForConsumers/Consume ... 173401.htm
Concerns Voiced by the Public Health Experts About Electronic Cigarettes
http://www.fda.gov/NewsEvents/PublicHea ... 173175.htm
http://www.fda.gov/downloads/NewsEvents ... 173405.pdf
http://www.fda.gov/downloads/Drugs/Scie ... 173250.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/sh ... 9cv0771-54
https://ecf.dcd.uscourts.gov/cgi-bin/sh ... 9cv0771-55

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/PublicHea ... 252360.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/Labe ... 339928.htm
Draft Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
http://www.fda.gov/downloads/TobaccoPro ... 271239.pdf
Draft Guidance: Establishing a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
http://www.fda.gov/downloads/TobaccoPro ... 334750.pdf
Exemption from Substantial Equivalence
http://www.gpo.gov/fdsys/pkg/FR-2011-07 ... -16766.pdf
New Tobacco Product Review and Evaluation
http://www.fda.gov/TobaccoProducts/Labe ... efault.htm
Draft Guidance: Applications for Premarket Review of New Tobacco Products
http://www.fda.gov/downloads/TobaccoPro ... 273425.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/petitions/% ... n=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 ... ode=normal
https://collaboration.fda.gov/p95861884 ... ode=normal
https://collaboration.fda.gov/p36279658 ... ode=normal
https://collaboration.fda.gov/p20988129 ... ode=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.
http://www.regulations.gov/#!docketDeta ... 012-N-1148
http://www.e-cigarette-forum.com/forum/ ... d-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/petiti ... d/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/Guid ... 348930.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/ ... 368992.htm
http://www.fda.gov/TobaccoProducts/Publ ... 369005.htm
http://prevention.nih.gov/tobacco/tcors.aspx
http://www.nih.gov/news/health/sep2013/od-19.htm


This post was originally posted by Bill Goodshall of Smokefree Pennsylvania on ECF, you can veiw the thread here: http://www.e-cigarette-forum.com/forum/ ... bacco.html
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Re: Urge Congress to prevent the FDA from banning......

Postby tjs » Thu Oct 10, 2013 2:48 pm

Just thought posting my latest letter to our representatives may help those who want to get involved in any way with some creative direction.
Feel free to use or omit any of the content to contact your local/federal elected official if it helps. :idea:
It only takes few minutes of your time and a valid address and email to do so. I have been too busy to participate as often as I would like here, but I made an exception today. The CASSA Call To Action For this specific ban and letter was http://blog.casaa.org/2013/09/call-to-action-demand-action-on_30.html but may apply to all states. Good Day All! :wave: 

Dear_____________ (Name)

I am writing this letter to ask your consideration and assistance in helping to STOP the FDA from banning electronic cigarettes, and giving the market to big tobacco companies. I am of course in favor of a safe and open market place and I urge you to consider these options.

I wanted to make sure you were aware that this is an important issue and in hope that you will do everything you can to prevent the ban and hand over of the market to the likes of the Big Tobacco companies. Being what I consider the “working poor” because of too much government involvement, regulations and control my believe and personal experience in the electronic cigarette field this would be a bad decision.

The “deeming” regulation would ban all e-cigs currently on the market per Section 910. The FDA already unlawfully banned e-cigs in 2009 until federal judges struck it down in 2010. The FDA has made false and misleading fear mongering claims about e-cigs since 2009. This “deeming” regulation would give the entire electronic cigarette industry to Big Tobacco (and perhaps a few large e-cig companies) even if the FDA exempts e-cigs from Section 910.

Some Quick Facts:
Virtually all e-cigs are consumed by smokers and ex-smokers such as myself who switched to e-cigs to get off or curb the use of regular tobacco filled products, The CDC has falsely claimed e-cigs are addicting youth and are gateways to cigarettes if the States (not FDA) would ban e-cig sales to minors this would be prevented 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. That would be a shame as they are less hazardous and great alternative to cigarettes. Additional FDA regulations for e-cigs would deny me and other consumers of legal and affordable access to e-cig products that many now consume.

The subject and safety of any relatively new product always comes into question and with warrant. Many of the latest studies are being published by notable health professionals on the subject of e-cigarettes and their uses are positive. Electronic cigarettes are also “Not Smoking Cessation products” but merely a smoking alternative. Are they 100% safe? No, but neither are cell phones or other electronic devices that are used every day by the general public. All products will carry some type of user risk. And the e-cig if used with even a small amount of care is very safe E-cigarettes have been proven reasonably safe with minimal care in the state they were designed to be used and sold.

The electronic cigarette is being compared to a regular tobacco cigarette only because the operation mimics the actual look and feel of their tobacco counterpart. Monitoring, taxing and restricting the sale of these devices is like comparing “apples to oranges” in every other way. Yes they are available in nicotine and non nicotine strengths, but any legal smoking age consumer should have the right to choose for themselves whether the electronic cigarette option is right for them without FDA and “Big Tobacco” involvement. Almost all e-cig retailers and manufactures (including online) have strict age purchase restrictions in place with mandates or government involvement.

Question?
The health care industry should be welcoming electronic cigarettes with open arms if all the data on smoking is true. With increased pressure on tobacco use and premiums that smokers supposedly cost all of us, you would think they would support the product.
So why haven’t they embraced this electronic vaping device? With large amounts of success stories and information on the subject, is the FDA truly looking out for my best interest? I highly doubt that and I detect other motives on this “deeming regulation”

In conclusion Mr.,___________(name) I would appreciate any assistance your office may provide on this matter.
I apologize for the length of this letter and if you have any questions about the use, operation or safety of the electronic cigarette that may help you understand the importance of any such legislation, please feel free to contact me.

Thanks in advance,
(name)_________________– Former Smoker _____ years.
TJS
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