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Fourth Call to Action for FDA Proposed Regulations
Streamlined Version

CASAA has been producing and posting FDA Alerts and Calls to Action since before the proposed regulations were released. For a full background on this issue, please go here:
http://blog.casaa.org/search/label/FDA

However, we realize there are recent adopters of these products who may not have had time to familiarize themselves with the politics and what is at stake.
In an effort to engage you and provide a means to have your voice heard, the following is a simplified version of our 4th FDA Call to Action. (For those who have thought about this before and want to maximize the impact of their comments, we urge you to instead send the more detailed letter described in the 4th FDA Call to Action: http://blog.casaa.org/2014/07/fourth-call-to-to-action-for-fda.html)

FDA Deeming Regulation in a nutshell:  
  • Unless you use only the cigalikes produced by the largest manufacturers, the products you currently use likely won’t survive this regulatory process.
  • Companies that produce the advanced products do not have enough money to pay for the FDA-created paperwork burdens.
  • These paperwork burdens are not about actual health, safety, or quality control issues and provide absolutely no benefit to consumers.
  • The result will be the elimination of the diverse products that offer smoke-free alternatives to smokers.
  • Many vapers will likely return to smoking or be forced to buy products on the black market.

What the FDA needs to hear from you:
  • The importance of not imposing regulations that would eliminate the legal market for all e-cigarette products other than mass-production cigalikes from a handful of large companies.
  • The difference e-cigarettes have made in your life (for example, substantially reducing or eliminating your smoking habit).
  • Why flavors make e-cigarettes such a successful alternative to smoking.
  • The impact on you if the products you currently use become illegal.

Here are four basic steps to craft and submit your comment to the FDA:

(1)  Copy and paste the following into a word document (any of the following formats are acceptable: .doc, .docx, .rtf, .txt, as well as .bmp, .xls, .pdf, .gif, .htm, .html, .jpg, .jpeg, .png, .ppt, .sgml, .tiff, .wpd, .xml, .xlsx, .pptx):

From: [your name]
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38


(2)  Compose your message (5000 characters or less) in the aforementioned word doc.  (If you want to write more than 5000 characters, you can upload your comment as an attachment.)  We suggest you consider including the following (but you can make this as simple as telling your personal story if you wish--this is YOUR comment):

  • Explain to the FDA that you are a consumer, and you are the primary stakeholder in this process.  Regulations are supposed to benefit consumers, but these actually harm you.
  • Your personal story of using e-cigarettes
    • How long / How much did you smoke?
    • Have you quit or significantly reduced your smoking due to e-cigarettes?
    • Have you used FDA-approved quit products? How did that go?
    • What are the benefits you’ve experienced since you started using e-cigarettes?
    • Have you noticed an improvement in your health?
  • If you use flavors, how has that helped you smoke less or stay smoke-free?
  • What you would do if the proposed restrictions were put in place and the products you use would disappear from the marketplace.
  • A closing paragraph (Tell them you’re a member of CASAA.  If not, JOIN  and then tell them!)

SAVE your comment. (You’ll need it later).

(3) Submit your comment to the FDA
http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0189-20870 
You can copy & paste your comment into the field provided on the FDA website
and/or upload your word doc file.

(4) #TellYourFriends 

             - and -

Please send the comment number to: casaa.fdacommentarchive@gmail.co
 


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