Document ID: FDA-2014-N-0189-5110
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller:

I'm submitting this as an individual consumer, concerned with your recent deeming proposal, 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 feel that the Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of electronic cigarettes that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions, which I might want to respond to. I would like to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing relevant comments on these important questions is very limited. I have already spent many hours researching and dissecting these issues, but they take time. It is clear that the FDA took many years to come to its Proposed Rule, and I feel that it is not at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide you our feedback. 

From experience, I know e-cigarettes can be a better alternative to combustible cigarettes. I truly believe that after trying to quit countless times, I would still be using traditional cigarettes if I had never been introduced to an e-cigarette. Now after a year there are days where I rarely, if at all, need my e-cigarette. I am no longer beholden to the hourly cigarette craving I got from traditional tobacco, and agitation it brought.  I would love to provide you with my personal story, as well as science -and evidence-based responses to the questions you have been raised, 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, of which I feel there are many, 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.