Document ID: FDA-2014-N-0189-8318
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing you today as an individual consumer and am requesting an extension of the comment period for the Food and Drug Administration’s 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 Act. I am asking that the FDA extend the comment period for the Proposed Rule for an additional 105 days, from its current 75-day period. 

The Proposed Rule raises a number of questions and concerns and deals with serious issues that are both important and relevant to me as a consumer of the products selected for regulation. This Proposed Rule asks a large number of questions that I might want to respond to. Before the comment period expires I want to provide my thoughts and comments on the issues raised, but the time I’m able to dedicate to researching and providing a thorough response on these important questions is extremely limited. I have painstakingly researched these issues, and am examining them to reach a better understanding, but this process takes time. 

Given that the FDA has taken many years to deliver the Proposed Rule, I think it’s fair to grant consumers like myself who have an interest in these issues an extension in the comment period.

I feel strongly about e-cigarettes as a viable alternative to combustible tobacco. These products are responsible for allowing me to quit traditional cigarettes, and I firmly believe that my use of this smoking alternative has saved my life, and the lives of my friends and family who have also made the switch. I want 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, and I feel that by extending the comment period from its current 75-day period, to 180 days will allow me to do that. 

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 several times in the past. With that said, I ask that you do the same here, so that those concerned with the proposed regulation are given the best opportunity to provide you with their comments.

Thank you for allowing me the opportunity to contact you regarding these matters and I appreciate your consideration of my request.