

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

General Comment:May 13, 2014

Dear Mr. Zeller:

I am writing as an individual consumer 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 a number of significant issues and questions that are 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 I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life.  I was a 2-3 pack per day smoker for 40 years and had unsuccessfully tried to quit numerous times.  A close friend suggested I try e-cigarettes as an alternative and though I had tried them before with no success, I tried again.  I tried the more expensive devices with various flavored e-juices instead of the cheap disposables and I found them to my liking.  In a matter of 2 days I was free of cigarettes.  For me I feel they saved my life since my father was a heavy smoker like me and he passed away due to emphysema.  My friends noticed the difference in me immediately.  My eyes were bright and clear again and my complexion changed.  I no longer coughed and I could feel my energy returning.   This is just my personal story and I would like to research more to provide science- and evidence-based responses to your questions so that you can take my comment 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 have the opportunity to provide their comments on this proposed regulation.

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

Thank you for your consideration,
Steven Mungeer
