Document ID: FDA-2014-N-0189-7262
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I write to you as an individual consumer and do hereby 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 my behalf, I request that the comment period for the Proposed Rule be extended by the FDA for an additional period of at least 105 days, from the current 75-day period, to a total of at least 180 days.

The Proposed Rule raises many significant issues and questions that are of extreme importance and relevance to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks a large number of different questions that I may wish to submit a response to. For those questions I may wish to provide my thoughts and comments on in relation to these issues, my available time to devote to researching and providing thoughtful and substantive comments on these extremely important questions is quite limited. I have to date invested a large number of hours researching, investigating and analyzing  these issues. I am aware that the FDA has taken many years to develop the Proposed Rule and thus do believe it is not at all unreasonable to allow me and all interested individuals of the general public an additional six month period to comment on these very significant and complex issues. We have but one opportunity, as consumers who are directly affected by the Proposed Rule, to provide relevant and substantive information regarding this issue to the FDA.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Simply put, I firmly believe that they have saved my life. I therefore wish to provide you with my personal testament, as well as scientific analysis and evidence-based responses to your questions so that you may consider my comment throughout this process. The FDA has the authority under 21 CFR 10.40 to extend this time frame and the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, such that all stakeholders may have the opportunity to submit their comments on this proposed regulation.

I sincerely appreciate your kind consideration of my request and would be happy to discuss any issues with you at your request.