Document ID: FDA-2014-N-0189-5633
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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 smoked 2 packs a day of tobacco cigarettes for 37 years.  I had tried numerous times to quit smoking using patches, lozenges, prescriptions, “cold turkey”, and even nicotine inhalers.  None of them worked.  I always went back to tobacco.  I have now been vaping for almost 5 years.  I started vaping to merely cut down on my tobacco use to save money.  By the end of my first week I was down to 5 cigarettes a day from 40.  By the end of 6 weeks, I had completely quit tobacco.  I LOVED to smoke prior to vaping e-cigarettes.  I also have dramatically improved my health.  My doctor is amazed at how clear my lungs sound now.  I used to get really bad bronchitis about 4 times a year.  Now I don’t have that problem.  I can smell and taste much better.  I realize we need a lot more research in this area.  But please give us the extra time to make our voices heard.  Tobacco use has been proven to cause many lung diseases including Cancer.  Many homes are burned down and lives have been lost due to the use of tobacco and children playing with lighters.  As a nurse I realize anything we put into our bodies is  “at your own risk.”  But I feel from interacting with many people that have quit tobacco completely,  with the assistance of vaping e-cigarettes that they are definitely a reduced harm alternative.  I would ask you to allow us to continue vaping e-cigarettes while medical trials are conducted.  The same way tobacco had the same opportunity before the surgeon general’s warnings went on the cigarette packs.  And still, we now know the dangers of smoking tobacco, and they are still allowed to be sold.