Document ID: FDA-2014-N-0189-5358
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller:
This request is being made by an individual consumer, to ask for an extension of the comment period for the FDA’s 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. 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 questions that are important to me, and about 100 of those are questions that I might want to respond to. However, the time I have to devote to research on these issues is limited, and it will take time to provide thoughtful comments. I have already invested many hours dissecting these issues, but these things take time. The FDA has taken many YEARS to even come up with the Proposed Rule, so asking for a few more days for the consumer is not an unreasonable request. This will be our only opportunity, as consumers, to provide our feedback, and it is the consumer, after all, that will be affected the most.

I feel very strongly about e-cigarettes as a much healthier alternative to the usual combustible cigarette. To be quite honest, Mr. Zeller, I firmly believe that the use of electronic cigarettes will afford me a longer, healthier life to spend with my family. I would like to provide you with my personal story, in addition to science and fact based responses to your questions. Quite frankly, electronic cigarettes are saving my life, and I deserve for my voice to be heard. I know that the FDA has the authority to extend this time frame, and they have exercised that authority numerous times in the past, under 21 CFR 10.40. I therefore ask that you do so here, in this case, so that all people involved will be afforded the opportunity to provide their comments on this proposed regulation.

I sincerely appreciate your consideration of my request. I would be happy to discuss this issue with you further at a time convenient to you.