Document ID: FDA-2014-N-0189-6259
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:
Mr. Mitch 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 formally 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. This Proposed Rule asks nearly one hundred separate questions, many of which I wish to personally 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've already spent countless hours researching these issues, but it will take more time. I am aware 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 and advocates for harm reduction, to provide our feedback and insight; this issue affects millions of people, whether directly or indirectly, and is an important step into the future.

I feel very strongly about e-cigarettes as an alternative to combustible tobacco cigarettes. I smoked a pack-and-a-half of tobacco cigarettes for 20 years, and after unsuccessfully trying every available smoking cessation method available (nicotine patch, gum, lozenge, etc.), e-cigarettes worked for me. I'll gladly provide you with my personal history, as well as science- and evidence-based responses to your questions, so that you can take my forthcoming 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. As American citizens, we have the right to determine what is best for us and to make informed decisions and determinations about our own health. 

I appreciate your consideration of my request and will gladly discuss this further with you if desired.