Document ID: FDA-2014-N-0189-7844
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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 huge 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 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 hours researching and dissecting these issues, but this takes time. I know that the FDA took many years to  come up with the Proposed Rule, so I do not think it is 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. 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. 

My husband and I have both smoked traditional cigarettes for 25 years. We have had the desire to quit smoking for years. We tried the available nicotine replacement therapies- gum, patches, and lozenges as well as "cold turkey" with absolutely no success. We weren't able to go even 24 hours.  I tried an electronic cigarette about 3 years ago.  It worked okay, but it wasn't enough to help me cut my ties with traditional cigarettes.  Around March 15, 2014 my sister told me she had purchased one of the new models of personal vaporizers and had not smoked since Feb. 14, 2014. My husband and I discussed it and decided to buy them with the intent of using them when smoking a regular cigarette was not acceptable.  I do not mean inside public buildings or public spaces where cigarette smoking is not allowed.  I mean in our private spaces where it is our decision to allow smoking or not.  Imagine our surprise when we drove from the store we purchased them at to our home without lighting a cigarette.  We did not even have the desire for one. We vaped the whole way home. During the course of the next week, I smoked 11 traditional cigarettes and my husband smoked 9.  Not because we w, ere trying to quit cigarettes.  It just happened.  The personal vaporizer/electronic cigarettes filled our needs. We started by purchasing 2 bottles of high mg. eliquid (equivalent to full flavored cigarettes). One was grape flavored and one was coffee flavored.  When we went back to purchase more we decided to give the nearest lower level of nicotine a shot.  Wow.  We had no problems bumping down to the lower level nicotine. It is now May 17, 2014 and we are using the lowest mg. and are prepared to start mixing the 0 (zero) mg. eliquid with it to cut it even further.  We are weaning ourselves off of nicotine completely. We are so thankful to have had these tools available to us at a very affordable price and to have the option to choose what levels of nicotine we needed for our journey. We are thankful to have had the control to choose our levels of nicotine and time frames in which to lower them. Also, the wide variety of flavor options have played a huge role.  My favorite flavor choices are chocolates, fruits, candy, and bakery flavors. 

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 a fair 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.