Document ID: FDA-2014-N-0189-5232
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment: Dear Mr. Zeller:

I am writing as a 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 at least an additional 105 days, from its current 75-day period, to a minimum of 180 days.

I have already spent many hours over the last 18 months researching and dissecting the issues of E-Cigarettes and Nicotine. 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 study and comment on it. 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. 

This is our only opportunity, as consumers, to provide our feedback.

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. 

Additionally, I find that review of the 194 cited references is extremely difficult due to:
 1. The overwhelming number of citations that are copyrighted and otherwise difficult if not impossible for the general public to access

 2. Citation numbering errors within the document itself and discrepancies between internet published versions on regulations.gov and federalregister.gov (i.e., references 153, 154, and 154a)

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 (eager) to discuss this issue with you further.