Document ID: FDA-2014-N-0189-5345
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller:

Greetings! I write to submit my request, addressing you as an individual consumer, to extend 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 my own behalf, I hereby request that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days.  That would increase the comment period from its current length of 75 days, to a total duration of 180 days.

I am a consumer of products that are proposed for regulation under the Proposed Rule; therefore, the Proposed Rule raises a number of significant issues and questions that are important and relevant to me personally. There are approximately 100 questions asked by the Proposed Rule that I might want to respond to. Since I desire to comment on these questions, I need more time to be able to fully prepare and provide my comments. I have spent some time studying the Proposed Rule already, and it makes me believe that the 75-day comment period is inadequate for me to fully prepare my my comments. It took the FDA a long time to come up with the Proposed Rule, and all I request is more time to provide comment on it. As a consumer, this is my only opportunity to provide our feedback. The longer comment period would be helpful, and in fact I feel it is necessary.

I have strong, positive opinions about, and feelings toward, e-cigarettes as an alternative to combustible cigarettes. I believe e-cigarettes have saved my life, because I was able to quite smoking by using them. I want to provide you and the FDA with comment that includes my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account.  That is why you should increase the comment period.  Under 21 CFR 10.40, the FDA has the authority to extend the comment period time frame (and the FDA has exercised that authority on numerous occasions in the past). Please extend the comment period in this instance as well, so all stakeholders have the opportunity to provide well-prepared comments on this proposed regulation.

Thank you very much for your time and attention, and for considering my request.  I would also be happy to discuss this issue with you further at any time.