

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

General Comment:
Dear Mr. Zeller:

This is an issue which has affected my husband and I greatly over the past 4 years.   I am not a scientist but I do know how the use of so-called electronic cigarettes has drastically changed our lives for the better. I also know for certain of at least 20 other people who have been helped by these devices.  So while it may be called anecdotal, at what number does it become a fact?




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. It seems to require me to prove a negative which is almost impossible for me to do.  I do 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 unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. 

IAs I'm sure you have gathered,  feel strongly about e-cigarettes as a less harmful and viable alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life, my husbands life, and at least 3 other people who I have helped get off of combustible cigarettes. 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 can tell you that in my efforts to quit smoking I had tried the following under a physicians care and supervision: Nicotine gum, Nicotine patch, Bupropian, Chantix, Counseling sessions, smoking cessation classes.  With the personal vaporizer and FLAVORED e-juice with nicotine I was able to quit smoking with no cravings or weight gain whatsoever.  If someone tells you that flavored e-liquid is a gateway to smoking, I must counter with the fact that it was a gateway to my quitting.  And YES I like strawberry and cotton candy flavored e-juice and I am proudly turning 55 on May 20, 2014, I was a smoker for 37 years.




I do however think you need to rethink childrens candy flavored meds tho.  I have no doubt that good tasting meds have been responsible for more overdoses than we are aware of.  Not really as different as apples and oranges.


I appreciate your consideration of my request and am happy to discuss this issue with you further.



 





Respectfully,




