Document ID: FDA-2014-N-0189-5917
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 a consumer of electronic cigarette products 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 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 the products that will be regulated under the Proposed Rule. Having read the Proposed Rule it asks about a hundred different questions I feel I would want to respond to. Being how the answers to these questions directly impact me, I want to provide my thoughts and comments on many of these issues. However, working full time and providing support in my household limits my time to devote to researching and providing thoughtful comments on these very important questions. I have already spent many hours researching and dissecting these issues, but they take time. I have concerns that such a short time period for forming quality responses to the many questions asked is not sufficient and that my true voice will be missed, or possibly dismissed in the process. It is my understanding that the FDA took many years to even develop the Proposed Rule. I do not think it is at all unreasonable to allow the public six months to comment on it. This will be my only opportunity as a consumer of the product being proposed for regulation to provide feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I firmly believe that they saved my life and have great potential. 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.