Document ID: FDA-2014-N-0189-6645
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 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 went from smoking 3 packs of analogs per day to zero in less than 24 hours. On November 10, 2013 my family Dr. offered to help me purchase a personal vapor device because I had a severe upper respiratory infection that wasn't clearing up. He suggested this after a patient of his started using a personal vapor device, She has been a patient for 35 years and he had never heard her lungs clear. So shocked he thought his stethoscope was malfunctioning. The day she left he started reading and studying everything he could find on the subject and the only thing in his opinion that was questionable was the nicotine and it was far less harmful than everything that 1 analog cigarette contained. He said nicotine was prescribed to some heart patients. Since I began using a personal vapor device, he has called on me several times to talk to other patients about my experience. I have been able to put my money on things like eye exams, dental care, and new school uniforms for my children. Their lives are better and if the FDA chooses to make it impossible for me to afford the things I need to vape all of the good so far will go away. 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.