Document ID: FDA-2014-N-0189-6183
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 concerned 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 important issues and questions that are relevant to me as a consumer of products that are proposed for regulation under the Proposed Rule. 

The Proposed Rule asks a number of questions that I might want to respond to. I want the opportunity to provide my thoughts and comments on many of these issues, but as a working parent, the time I have 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 that takes time, and the Proposed Rules address questions that require additional research. 

Understanding that the FDA took many years to develop the Proposed Rule, 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 our feedback, and I am respectfully asking for that consideration. 

I feel very strongly about e-cigarettes as an alternative to traditional, combustible cigarettes. 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 understand 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.

Thank you in advance for your consideration of my request.  I am happy to discuss this issue with you, or any member of your team.