Document ID: FDA-2014-N-0189-7964
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing, as an individual 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 to 180 days.  This would add 105 days for review and comment generation. 

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 raises hundreds of different questions I might want to respond to. I don’t have the luxury of devoting full time to providing my thoughts and comments on many of these issues.  I need time to research and provide thoughtful comments on these rules that, on first review, appear to adversely impact public health.  I have already spent many hours reviewing and researching these issues, but they take time. The FDA took many years to arrive at this Proposed Rule.   I not only believe it is reasonable, but also imperative, to allow the public six months to review and comment. As consumers, it is imperative that we be allowed appropriate time to provide our feedback.  Unlike Congress, I believe regulations should be read, researched and understood prior to putting legislation in place.

I feel very strongly about e-cigarettes.  As a former 43 year, 2-3 PAD smoker who tried quitting dozens of times with FDA approved products, I feel I have some expert knowledge on what works and what doesn't.  I believe that e cigarettes have improved my health and extended my life. I wish to provide you with more detail of my personal story, as well as including scientific and evidence based responses to your questions so that you can take my comments into account. 

I am aware that the FDA has the authority under 21 CFR 10.40 to extend this time frame.   I am also aware that the FDA has exercised this authority on numerous occasions in the past.  I would therefore ask that you do so here.   There are some 47 million stakeholders that this regulation may negatively effect and time is needed for appropriate response on this important rule. I appreciate your consideration of my request and look forward to discussing this issue with you further.