Document ID: FDA-2014-N-0189-7323
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.

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 had been a 3 pack a day smoker for over 37 years.  As a result of putting all of the many chemicals found in cigarettes into my lungs for so long, I now have COPD.  I have had to use a nebulizer and 2 different types of inhalers for the past few years, and even with the breathing issues I was still unable to quit cigarettes.  I tried unsuccessfully many times with the same result, I was still smoking.  In April 2012 I had to visit the ER, because I was sure I was having a heart attack.  Thankfully I wasn’t, it was yet another problem with my breathing.  The Doctors told me I had to quit smoking.  I started doing research and found Electronic Cigarettes and bought a kit right away.  It is now 2 years later and I am happy to say I am smoke free.   I have improved my breathing issues immensely.  I do not need to use my breathing medicines  at all.  I recently went to my Doctor for a routine check up and She was very happy and impressed with my improvement and gave me her blessing on continued use of the e-cigs 
 I have reduced my nicotine level from 2.4 mg to .3 mg since starting in 2012.  This alone is proof to me that electronic cigarettes are not a gateway to smoking but rather a way to successfully close the door on smoking.  
It is my opinion that yes some regulations are welcome from the FDA, such as: prohibited sale to minors, child safety packages and clear precise labeling on packaging, however to heavily regulate or classify e-cigs as a tobacco product would do a great injustice to the many that have successfully quit cigarettes or to future smokers looking for a way to quit by using e-cigs. 
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.