

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 have been a smoker of combustible cigarettes for over 8 years; in this time I've had numerous issues with coughing, wheezing and general lung discomfort and pain. When e-cigarettes first entered the market I tried them. They didn't help me give up combustible cigarettes any easier, or with any permanence than the other options out on the market for nicotine replacement(the patch, gum, lossenge, etc.). Frankly, these are all replacements, not cessation aids. Every time I have attempted to use any of the other replacements my personal and professional life has suffered due to withdrawal of nicotine. Every time I have gone back to smoking combustible cigarettes within a few months time. I have since switched over to e-cigarettes of today a month ago, and immediately ceased smoking combustible cigarettes and have since had no lung pain, coughing or wheezing. I have been able to begin working out on a regular basis to increase my personal health with no suffering to my personal or professional life and remain a productive citizen. I have been a more pleasant person and have been drastically decreasing my nicotine intake as well through the use of lower nicotine concentrated e-cigarette liquids. E-cigarettes have drastically changed my life for the better and the proposed regulations could very well put that in danger.

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.

