Document ID: FDA-2014-N-0189-5357
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I was a smoker for almost 16 years, starting at the ripe age of 14.  I continued to smoke cigarettes until May 14th, 2013.  That is the day that I got my first Electronic Cigarette starter kit and began trying to kick cigarettes.  On May 15th only one day later, I smoked my last cigarette.  I have now been cigarette free for 3 days shy of 1 year.  I had tried to quit smoking in the past with patches and gum and even just cold turkey (that one got me further than gum or patches).  To no avail, I never could seem to stay on track, always going back to the cigarettes in the end.  Only this time it has been drastically different, within the first week of Vaping, I noticed everything getting better, sense of smell, breathing, mood and energy.  Once I noticed that my life quality was improving I never looked back and now almost one year later, have lowered my nicotine intake from 24mg juices to 6mg juices and have never felt better.  I have not yet experienced any side effect of Vaping thus far, which in any case is a whole lot more than I can say about cigarettes.  Vaping has truly changed my life for the better and while I want to make sure it is as safe as possible for Vapor’s and the general public, I also know that these regulations will make it nearly impossible for people to have the chance that I did.  It is with that I ask of you to strongly consider the extension time period being granted, so we can attempt to provide the correct research necessary to come up with reasonable and respectable regulations so that we don’t bankrupt a hugely growing industry that if nothing else is providing a safer alternative to cigarettes and carcinogens.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

  

                                  Sincerely, 
                               James Decker