Document ID: FDA-2014-N-0189-4674
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-15T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing as an individual consumer to request an extension of the comment period for the 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, 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 many different questions I might want to respond to. As a responsible user of e-cigarettes, I do not find it unreasonable to request an extension of the comment period, especially when considering that the FDA spent such a considerable amount of time coming up with the Proposed Rule. While many of us truly wish to provide informed, thoughtful feedback, there are many hours of reading and research that we need to do, and this is the only opportunity that consumers will have to provide you with our feedback. Most of us have limited time to devote to such issues, in spite of how important they are to us and how big of an impact they may have on our lives, and can only devote a few hours per week reviewing the extensive document outlining the proposed regulations.

In short, I believe that e-cigarettes have saved my life, and have the potential to save the lives of many others. 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.

Thank you for your consideration, and I would be happy to discuss this issue further.