Document ID: FDA-2014-N-0189-6856
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller,

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 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 large number of significant issues and questions that are important and relevant to me, as a consumer of the products that are proposed for regulation under the Proposed Rule. I want to provide my thoughts and comments on these issues, many of which are going to take a significant amount of time, energy, and research in order to address in the way which they should; thoughtfully, thoroughly, and judiciously. I do not think that requesting an extension for open commenting is at all unreasonable.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I firmly believe that they have increased my health and have extended my life. After twenty-five plus years of smoking, and numerous failed attempts at trying to quit combustible cigarettes in the past, I finally found an alternative that actually works. It is amazing how effective this method has been for me, and the large number of other ‘vapers’ out there who have used e-cigarettes as a Tobacco Harm Reduction (THR) method as well. I sincerely urge you to listen to the people who have struggled with quitting for so long and to hear their stories of success by switching to e-cigarettes. While I agree that some regulation is necessary, these proposed regulations and financial burdens you set forth will, in essence, eliminate the tools necessary to keep this industry alive, not to mention the thousands of small businesses that will be put out of business. Shrouding these regulations in the guise of ‘protecting children’ is honestly just a subterfuge, and quite insulting to me as a parent. I don’t truly believe that you want to protect my children, nor have I asked you to, nor do I need you to. Vaping is not a problem; it’s an extremely effective solution to a much more dangerous problem. There is obviously a larger agenda at play here that has nothing to do with children, the future health of our society, or the freedom to choose, as an American, a healthier lifestyle for myself and that is truly a shame. 

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 us involved have the opportunity to provide our comments in the best way possible.

Your consideration of my request is greatly appreciated.