Document ID: FDA-2014-N-0189-41112
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-09T04:00Z

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 have already spent many hours researching and dissecting these issues, but they 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. 

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.
I am a former smoker. I smoked for 20 years. I had tried to quit countless times, using every FDA approved method, like nic gum, lozenges, the patch, the inhaler, chantix, and welbutrin. All ending in failure after not before a period of discomfort, frustration, and even shame was endured. The longest I had ever made it smoke free was four months. Achieved only under extreme duress. My personal and work life suffered during these times. I tried my first e-cig in 2009 and I must say it wasn't very good. About two years later i tried another e-cig and it was better but I couldn't find something that really hit the spot. But in early  2013 when my mother was diagnosed with COPD brought on by her fifty plus years of smoking. I decided to try a new kind of advanced personal vaporizer "APV" that was recently on the market. It was noticeably larger than a cig and didn't resemble one either. It was the kind you put E-liquid into and have ability to adjust the power to suit your taste. I still remember that day vividly. I was near tears realizing that I had finally found a product that WILL work for me. That day was over a year ago, I haven't had a cigarette since. Not one, that combined with zero anxiety or discomfort. In fact the only anxiety related to switching using APV's is the thought that the FDA might take these of the market. The products I use are not the cigarette like e-cigs sold in gas stations. I use variable wattage and mechanical devices that offer much more effective performance. These are the kind of devices most average vapers actually use. These are the kind of devices that are threatened to be stifled if not completely banned from market for not passing the unfair application process. The devices being produced back in 2007 were without a doubt sub par compared to todays modern APV's. The rate of progress to improve vaporizers has been just enough as is. If we are forced to go back to 2007 devices and wait for possible approval for newer devices, it would destroy the industry as we know it. The Vaping industry supports thousands of small business’s  and reduces harm for so many. Why would we want to  kill such a positive initiative. There are obvious self evident regulations that FDA proposed regarding sale to minors, childproof cap, ingredient and warning labeling. I don't think there is anybody who would disagree with those. Its the application process and treating APV's like tobacco. Just because we get nicotine from the leaves of the tobacco plant, we do not roll, pack, chew, or most importantly combust. We get vitamin c from an orange. Do we regulate vitamin c supplements as a citrus product? That said I whole heartedly urge that we change the proposed regulation to eliminate the application/approval process and not classify my APV's and e-liquid as tobacco.