Document ID: FDA-2014-N-0189-6527
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Hello Mr. Zeller:

As an individual consumer, I've recently become aware there are pending regulations upon products that I have used to stop smoking.  My last cigarette was exactly 3 weeks ago today.

At any rate, I'm writing 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'm 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 these products. The comment period provides very little time for me to do further research, and I'd like to inform myself as thoroughly as possible in order to be able to make substantive comments that I feel comfortable with.  I've done quite a bit of study already, but I do understand the complexity of the issue and realize there is much more to learn.

Very briefly, I was a heavy smoker for 42 years who developed lung cancer which made it necessary to remove a lobe from my left lung.  Yet, I still struggled with method after method of smoking cessation and various products, becoming more and more hopeless with each failed attempt, until a friend showed me an electronic cigarette, and how it worked.  It took me approximately 4 months to stop smoking cigarettes entirely, during which time I transitioned from cigarettes to a personal vaporizer.  My friends and family are fairly amazed, but I'm the most amazed of all.       

I realize that the FDA has the authority under 21 CFR 10.40 to extend the time frame for comment and hope that it is able to do so.

Thanks for the opportunity to request an extentsion - I deeply feel that considering all that's at stake here, further study isn't a choice, it's a necessity.