Document ID: FDA-2014-N-0189-5511
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing 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, and for the sake of myself and my businesses, 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 absolutely critical to me, as a consumer of products that are proposed for regulation under the Proposed Rule, as well as a small business owner that services clients active in the nascent electronic industry. The Proposed Rule asks a multitude of different questions I might want to respond to. 

I want to share my thoughts and comments on many of these, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but the research and information gathering take time. I know that the FDA, wisely,  took years to come up with the Proposed Rule, so I feel that it is wholly appropriate to allow the public six months to comment on it. This is the only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I smoked a pack and a half of regular cigarettes for 27 years.  I have thankfully been smoke free for 1 year thanks to these devices.  I wish to provide you with the details from personal story, especially the medical impacts, as well as science- and evidence-based responses to your questions so that you can take my comments 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 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.

Anthony