Document ID: FDA-2014-N-0189-42876
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-14T04:00Z

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

General Comment:5/26/2014
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.
My name is Seth J., at the age of 28, I found myself unable to quit smoking traditional burned, cigarettes.  I have tried it all, cold turkey, the patch, the inhaler, the gum, the drugs (Chantix), I even tried hypnosis.  Until I discovered the invention known as an “Electronic cigarette.”  Within 2 weeks, I was smoke free, and immediately began my quest to lower my nicotine intake.  I began using Flavored E-liquid that was 28Mg/Ml of nicotine,  I quickly moved to lower, and lower, now I currently alternate from 6mg/Ml, to ZERO nicotine Flavored E-liquid.   The wide varieties of flavors was a crucial part of my success.  I began using butterscotch, then moved to cotton candy, watermelon bubblegum, etc, just to name a few flavors.   Banning these devices, or regulating them out of existence would be very bad for public health.  The FDA would essentially be saying to the American Public: “keep smoking, and dying, even though there is a viable 99% safer alternative to cancer causing combustibles cigarettes”.  I urge you to look at some studies I have posted below. 

I have been smoke free since 2012, and about to turn 31.  I am proof that E-Cigs save lives.  Just ask my doctors.  They have documented the dramatic affect E-Cigs have had upon my health and couldn't be more pleased with the results.

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

Sincerely, 
Seth J.

http://casaa.org/Tobacco_Harm_Reduction.html

http://casaa.org/Electronic_Cigarettes.html

http://casaa.org/Lab_Reports__ecigarettes.html

http://www.mdpi.com/1660-4601/10/12/7272 (Downloadable PDF of the Impact of Flavour Variability)

http://informahealthcare.com/doi/abs/10.3109/08958…(Downloadable PDF – Toxicology study on vapor proves electronic cigarettes are much better than tobacco)

http://www.mdpi.com/1660-4601/11/4/4356 (Downloadable PDF – Switching from cigarettes to e-cigarettes has significant health benefits, according to a survey of more than 19,000 users)

http://www.nature.com/srep/2014/140226/srep04133/… (Downloadable PDF – Nicotine Abosprtion from Electronic Cigarette use between “First generation” (pre 2007) and Third Generation Devices)

http://publichealth.drexel.edu/~/media/Files/publi…(Downloadable PDF – Chemicals generally found in E-Cigarettes pose no health concerns)

http://ecigarettereviewed.com/wp-content/uploads/2… (Downloadable PDF – Dangers of over-regulating E-Cigarettes)

http://www.biomedcentral.com/1471-2458/14/18/abstr… (Downloadable PDF – No Concern for Bystanders of Second Hand Vapor)

http://www.biomedcentral.com/content/pdf/1471-2458… (Downloadable PDF – Effect of E-Cigarettes on smoking reduction and cessation)

http://goo.gl/LhEDoK(Downloadable PDF – Study that found of more than 2000 former smokers in this survey, 96% reported that the e-cigarette helped them to stop smoking.)