Document ID: FDA-2014-N-0189-33779
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-03T04:00Z

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

General Comment:Dear Mr. Zeller,

As an individual consumer of e-cigarettes I would like 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. I would like to formally request 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 addresses many significant issues and asks numerous questions that I feel to be extremely 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. Most of which I would like the opportunity to address.  However, I am limited in the amount of time that i can devote to researching and providing relevant and helpful comments that address these important questions. I have already spent much of my free time over the past few years researching and dissecting many of these issues, but would require more time to formulate a direct response to the questions and issues that have been raised in the proposed regulations.  I do not think it is at all unreasonable to allow the public a mere six months to comment on these proposed rules considering it took the FDA years to come up with them. This is the only opportunity for consumers to provide our feedback. 

I am very passionate about e-cigarettes as an alternative to combustible cigarettes and i honestly believe that they have saved my life. In addition to sharing my  personal story, I would like the opportunity to provide science and evidence based responses to your questions. I know that the FDA has the authority under 21 CFR 10.40 to provide an extension to the time frame allotted for public comments and that the FDA has granted such extensions many times in the past. I would ask that you provide this extension in this case as well, so that all consumers and industry stakeholders have the opportunity to provide their comments on this proposed regulation.

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