Document ID: FDA-2014-N-0189-6339
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I'm 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. I neither manufacture or sell nor am I involved in the manufacture or sale of any e-cigarette products; I'm simply a 63 year old retiree and ex-smoker who has found them to be of very great benefit to my health, as have several members of my family and others in my circle of friends.

The Proposed Rule demands a careful reading. It 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 and discussing them with other persons who share my concern, but fully understanding the implications and impact upon my own life is very important to me. To do so requires 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. I have been using them for about 5 years now, after over 40 years of very heavy smoking despite numerous efforts to quit, including earnest trials with other products on the market (patches, etc.). I was able to stop smoking within a week by replacing cigarettes with e-cigarettes, with no ill effects and many benefits. I do firmly believe that they have saved my life. I wish to provide you with my full 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.