Document ID: FDA-2014-N-0189-5017
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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 am a mother of 3, and I also hold a job out side of the home. My daily time is limited and while I have already spent many hours researching and dissecting these issues, they do 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. Imagine if your employees only had 75 days to produce the document in question while working ANOTHER job and the impact that would have on their family. In 75 day commenting period I have my oldest child getting a drivers license, which in the State of Maryland requires 60 hours behind the wheel with a parent. He is also working while going to college, which I provide transportation for. My 15 year old is getting a learners permit(Another 60 hours of drive time) and is also going through AP testing while preparing to go to junior police academy in June, and the all important softball season. My youngest being prepared for entering middle school, with extra homeschooling in areas she is weak in at school. Those are just a few of my personal daily challenges. This doesn't include making dinner, paying the bills, grocery shopping, laundry,the children's extra curricular activities, getting my garden in, as we supplement our large food bill with home grown salads and other vegetable goods as well as a flock of chickens that require daily care. Add to that my full time employment. Even having time to read a paper can be a challenge. This issue is important to me. I would just like more time to prepare my comment, and right now I do not feel prepared.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as 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.