Document ID: FDA-2014-N-0189-5961
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller,

My name is Matt, and I am writing you today in regards to 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 Prevention and Control Act (the 'Proposed Rule') published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. I am writing you today specifically to request an extension to the Proposed Rule's open comment period.

As the Proposed Rule raises a large number of significant issues and concerns for myself (and, I would imagine, many other users of electronic cigarettes/other Tobacco Harm Reduction (THR) devices/methods), many of which are going to take no small amount of time, energy, and thought in order to address in the way which they should; thoughtfully, thoroughly, and with a level head. As such, I feel that 75 days is just nowhere near enough time in order to properly compose my response to the Proposed Rule.

I know that the FDA has taken over three years in order to come up with the Proposed Rule, and it shows. It's thought-out and thorough. I do not think that, given this fact (plus the fact that it's 241 pages long, along with an additional 81 pages of regulatory impact analysis!), requesting an extension for open commenting is at all unreasonable.

In light of this, I ask that you extend the Proposed Rule's open comment period by an additional 105 days, from the original 75, to a total of 180 days. A mere 6 months, in order to fully grasp all that the Proposed Rule will mean for those of us who will be affected by it, and to come up with comprehensive, respectful, and meaningful comments, so that we may be truly heard as the citizens of this great nation we are.

In case you hadn't yet gathered this, I feel very strongly about electronic cigarettes as an alternative to combustible cigarettes ('burn-downs'). I feel that, without the advent of these wonderful devices, and the associated accoutrement, I would still be smoking burn-downs, and would've been until the day I died of any of a number of insidious diseases directly related to my (previously) severe nicotine addiction, just as my mother did. I feel that e-cigs saved my life. Or, more precisely, extended it, especially the quality of life of my later years. I wish to provide you with my own personal story, as well as those of a large number of fellow 'vapers' (users of electronic cigarettes), many of whom come to me on a regular basis to tell me of all the wonderful benefits they're experiencing since quitting smoking. I would also greatly appreciate the opportunity to present you with science- and evidence-based responses to your/FDA's questions, in the hopes that a better-informed governmental entity is one that will be able to make better-informed decisions.

I understand that, under 21 CFR 10.40, FDA has the authority to grant an extension to the open-commenting time-frame, and that FDA has exercised this authority on numerous occasions in the past. The precedent has been set. All I am asking (as are all the others flooding your in-box) is that you do so in this case, so that all us involved have the opportunity to provide our comments in the best way possible. You, of all people, understand the need for time in order to put forth coherent, comprehensive responses to novel situations. Please, for the love of our citizenry, grant us these few months, in order to respond to that which has taken years to develop.

Your consideration of my request is greatly appreciated, and I am more than happy to discuss this with you further, should you so desire.

Sincerely,
J. M. Novak-Zarate