Document ID: FDA-2014-N-0189-6773
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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 appreciate your consideration of my request and am happy to discuss this issue with you further.                                                                                                                                                                                                                                                                                                                                                                                                  I was smoking for 30 years. In 2011 I stopped smoking with the help of ecigs. In fact I only smoked two Cigarettes since I started vaping. After 1 month of vaping I smoked half of a Cigarette when my battery died. I bought more batteries.  After three mouths of vaping I tried a cigarette to see what it would be like. I could not stand it. After one draw I got rid of it. I  never smoked another cigarette since. My mother had COPD from smoking. She passed away due to smoking in November 2010. I started having real problems from smoking in 2009. I had breathing problems. I could not even bend over to tie my shoes without losing my breath, I got dizzy at times breathing hard. I had a very hard time passing a Respirator test, almost losing my job. I also started getting sick a lot (Sinus/Chest Infections) from smoking. I was so bad I told my wife after the death of my mother that If I can not stop smoking I may die in 5-10 years but not before getting very ill with COPD. But In June 2011. I found something that Changed my life. I found ecigs. Its 2014 Now. I still vape. My breathing is normal again. I can run again. I can swim again My blood pressure is now on the low side of normal. I passed a deep check blood test. All normal. No longer getting sick from smoking. I stopped smoking Cigarettes because I am using ecigs. As long that I can vape e-cigs I will no longer smoke Cigarettes. The FDA registration requirement is a business closer. The FDA should partners up with AEMSA  (American E-liquid Manufacturing Standard Association). Allowing only E-liquid that is certified by AEMSA to be sold in the United States. I only use e-liquid that is certified by AEMSA.