

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

General Comment:Mr. Zeller:

I am writing as an individual citizen 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 numerous and significant issues, as well as 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 many different questions I want to respond to. I do 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 quite limited. I have already spent some hours researching and dissecting these issues, but they take time. I know that the FDA took a few 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 of these products, to provide our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Put simply, I firmly believe that they saved my life - I quit smoking combustable cigarettes, after more than 30 years as a smoker, in June 2011 using e-cigarettes. I've experienced numerous failed attempts with pharmaceutically-developed products (patches, gum, etc.). I've no question that e-cigarettes are, in fact, very effective and present far less potential harm than combustable cigarettes. I wish to provide you with more of my personal story, as well as science- and evidence-based responses to your questions so that you can take my comments 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.

