Document ID: FDA-2014-N-0189-4805
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:TO:
 Mr. Zeller

IN REGARDS TO:
 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. 
I am writing on behalf of myself, and 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 extremely important issues and questions, relevant to me, and could potentially have a crucial negative effect for consumers of products that are proposed for regulation under the Proposed Rule. 
This Proposed Rule seems to have dozens, if not hundreds of different questions I want to respond to. The limited amount of time available to thoroughly and effectively research all areas pertaining to the Proposed Rule is insufficient. It took years to draw up the Proposed Rule, and I feel that requesting a 105 day extension (6 months) is not only reasonable and appropriate, but necessary. The impact of not allowing consumers and affected businesses extended time to effectively research, understand and provide feedback and concerns could prove to be a devastating blow to the FDA in terms of negative public perceptions of what the FDA stands for.
The community of those who vape feel very strongly and are passionate about what E-cigs can do for people. Quite simply, they are saving lives. There is an undeniable correlation between E-cigs and the number of people who have successfully quit smoking. I hope you will acknowledge that E-cigs have had a tremendous positive effect for this nation’s large number of smokers, and I hope you will take the time to read and enjoy the personal testimonies of those who have found success. Upon the approval of an extension deadline, 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.