Document ID: FDA-2014-N-0189-6667
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:May 14, 2014

Dear Mr. Zeller:

I am writing to you today as an individual consumer.  I would like 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, extending it from its current 75-day period to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important to me as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks approximately a hundred different questions to which I would like to respond. I want to provide my thoughts and comments on many of these issues. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took several years create the Proposed Rule, so I think it is reasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumer and citizens of the nation to provide our feedback to our governing body concerning this particular issue.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. They have improved my health and my overall quality of 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 to discuss this issue with you further if you so desire.  Thank you for your time.