Document ID: FDA-2014-N-0189-4856
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 tobacco cigarettes. Quite simply, I firmly believe that they saved my life.  I started smoking cigarettes 30 years ago, when I was 14. I smoked upwards of a pack a day for more than 15 years. By age 17 I had developed asthma. From the ages of 21-28, I had bronchitis at least once a year. I have had various upper respiratory infections countless times. Last year I had a lung infection that was thankfully caught before hospitalization was necessary. At age 35 I was put on medication for high blood pressure. And every single time I got sick, every single New Year, every single birthday, I vowed to quit smoking. I tried everything, and even quit for a few months at time, then started up again. On August 13th, 2013, a friend introduced me to e-cigarettes, or vaping. I have been smoke free ever since. I no longer need an asthma inhaler, I no longer need blood pressure medication. I no longer live in fear that my only niece will find out I smoke, and that I will somehow have to explain to her why I choose to slowly kill myself with cigarettes. In a word- I am FREE.  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.