Document ID: FDA-2014-N-0189-8368
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing this as an individual who currently uses e-cigarette products and in order 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.  I request 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 am concerned with the manner in which e-cigarettes are being vilified in some media, using specious and fallacious arguments to make the argument against a product which has dramatically improved my life.  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 great number of different questions to which I might wish to respond. I would like 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 considering these issues, but they take time. I know that the FDA, itself, has taken many years to come up with the Proposed Rule, therefore, I do not think it to be 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 tobacco cigarettes. Quite simply, I firmly believe that they saved my life. I would like to provide you with my personal story, as well as science-based and evidence-based responses to your questions, so that you may 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 time and consideration of my request and would be happy to discuss this matter with you further.

Yours Sincerely,
Joe Avsenik