Document ID: FDA-2014-N-0189-5805
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller;

I am writing as an individual consumer to request an extension of the comment period for the FDA’s Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic 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 spend on researching and providing thoughtful comments is limited. I have already spent many hours researching and dissecting these issues, but they take a lot of time.  I know the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it.  This is our only opportunity, as consumers, to provide our feedback. 

I feel extremely strong about e-cigarettes as a alternative to combustible cigarettes. I truly believe that they have saved my daughters life as well as my own. I would love to provide you with my personal experience, 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 more than happy to discuss this issue with you further.