Document ID: FDA-2014-N-0189-5816
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 would also like to not that there is a considerable amount of science on this subject that has gone completely ignored apparently by the FDA and our elected officials done by Dr. Konstantinos Farsalinos. I urge you to consult with this person. 

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. Over 3 1/2 years ago as a 22 year smoker, I had a heart attack. 99% blocked in one artery and 80% in another. You would think having a heart attack would make you stop smoking immediately. Not the case. Not until I discovered electronic cigarettes. I quit the very first day I bought one and have not looked back. I also shared this with my cardiologist and he is thrilled I am no longer smoking. I can breathe better, taste better, and my energy level is way up. Electronic cigertettes are at least 90 to 99% better than the combustable counterparts. I also watched my father, a 3 pack a day smoker die at 47. I watched my stepfather struggle through two open heart surgeries and later emphysema. And in this past December, my mother passed away in house fire she started with a cigarette. This all could have been avoided if electronic cigarettes, one of the greatest inventions ever for public health, had been invented years ago.   

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 also urge you to do what is right for people. Not to pander to politicians, Big Tobacco and the pharmaceutical companyies whose market share is dwindling and rightfully so.  

I appreciate your consideration of my request.