Document ID: FDA-2014-N-0189-7307
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 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. After smoking for more than 20 years, a friend led me to an e-cigarette almost seven months ago, and I have never looked back. It is very evident that my lungs have returned to their previous state before I started smoking, as I do not cough, my chest is not tight, and my energy level is back to that of my young adulthood. And, just as important to note, I do not have any negative side effects as a result of e-cigarette usage. Many of my family and friends took note of my situation and converted to e-cigarettes, also, with approximately 90% achieving the same result of replacing combustible cigarettes with e-cigarettes. Most notable of these being my mother and aunt, both of whom smoked for over 40 years, and are now both in their sixth month without a combustible cigarette. I know that nicotine in general is not good for my health, but at least I am not ingesting the thousands of harmful carcinogens that are in combustible cigarettes. I firmly believe that e-cigarettes are the best alternative to combustible cigarettes for those of us not strong enough to quit cold-turkey. Please give myself and others more time to prove this to be true. 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.