Document ID: FDA-2014-N-0189-5379
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller,

I am writing as a concerned individual consumer of electronic cigarettes to request an extension for 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 Costmetic 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 significant number of issues and questions that are extremely relevant to me, as a consumer of the very products that are proposed for regulation under the Proposed Rule. There are a couple of hundred pages that raise as many questions that I would like to have the opportunity to respond to. Considering that the FDA had many people over a period of several years work on the Proposed Rule presents me with a serious imbalance because I can not, unfortunately, dedicate months of my time to write thoughtful and helpful comments on the extremely important issues that have been presented to me. I feel it is unreasonable to ask for thoughtful and well researched response in the relatively short period that has been allowed for such. The content of the Proposed Rule is of such utmost important to people’s lives, including my own, that I do not believe it would be unreasonable to request for an extension to this period. After all, this may be our first and only chance that we, the consumers of the products subject to the Proposed Rule, can provide our feedback.

I have strong feelings about electronic cigarettes and the alternative they present to traditional combustable cigarettes. I have no reason to doubt that they have improved my life and my health in ways I had never thought were possible and even allowed me to quit smoking altogether even though that was not originally my intention when I bought my first electronic cigarette.

I believe that under 21 CFR 10.40 the FDA has the authority to extend the period for feedback and comments and has a proven history of granting such extensions on numerous occasions. I would henceforth ask that you do so here as well in order for all stakeholders to have a more reasonable opportunity to provide comments on the Proposed Rule.

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

Sincerely,

Stefan Didak.