Document ID: FDA-2014-N-0189-6354
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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. After multiple tries at quitting smoking using various methods, I have found an alternative to tobacco that is helping me to quit smoking AND help me to wean myself off nicotine by having control of how much I have added to the “eliquid”. I have successfully gone from 18mg/ml to 6 mg/ml in the last 3 months and look forward to getting to 0 mg nicotine in the next few months. Being free from cigarettes after 23 years of smoking is a great feeling, and I can tell you first hand that vaping and smoking are nothing alike. I feel my health improving every month that I don’t smoke and my senses of smell and taste have improved immensely. These are just a few of the positive side effects that I have personally had while vaping. I also would like to point out that the “cigalikes” were not effective for me, and only after switching to a rebuildable tank and mechanical mod did I finally find what I was looking for. I also believe that some form of regulation is needed, but not the kind that destroys small business, creates a less desirable alternative to smoking, or allowing the big tobacco companys or big pharma control our products and usage. Give the little guys a break already. Age restrictions and labeling are common sense changes for the better, but some of these proposed regulations would possibly put thousands of tax paying small businesses out of business and make most of the equipment most of us use on a daily basis illegal and unavailable. That is not good regulation.

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.

Barry Byers