Document ID: FDA-2014-N-0189-5480
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 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 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 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. 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. I and many of my friends and colleagues have already spent many hours researching these issues, but it is a very difficult and time consuming undertaking.  It is my understanding that the FDA took many years to even come up with the Proposed Rule, so I feel it is only fair to allow the public and individual consumers a mere six months to research and effectively comment on it. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I have been using e-cigarettes for almost two years after switching from combustible cigarettes which I had smoked for 39 years.  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 those who chose to do so, have the opportunity to research the issue thoroughly so we are able to provide effective comments on this proposed regulation.

Thank you for your time and attention to my request.  I am happy to discuss this issue with you further and am providing my contact information.

Sincerely

Claudia H. Linse