Document ID: FDA-2014-N-0189-7035
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 e-cigarette user 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 many significant issues and questions that are important and relevant to me, as a user of products proposed for regulation under this Proposed Rule. The Proposed Rule asks dozens of questions I wish to respond to. I want to provide my thoughts, comments and scientific research about these issues, but my time to devote to researching and providing thoughtful comments on these vital questions is limited. I have already spent many hours researching and dissecting these issues, but will need more time. I know that the FDA took many years to even come up with the Proposed Rule, so it seems reasonable to me that the public be allowed at least six months to comment on it. This is our only opportunity to provide you with consumer feedback. 

I am passionate about e-cigarette use. Quite frankly, I firmly believe that they have enhanced the quality of my life. I wish to provide you with my personal story, as well as specific science- and evidence-based responses 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 would therefore ask that you do so here, so that all stakeholders, particularly consumers who use products purchased via the massive entrepreneurial business network that actually generated and grew this industry, have the opportunity to share their thoughts regarding this proposed regulation.

I appreciate your consideration of my request and would be happy to discuss this issue with you further.