Document ID: FDA-2014-N-0189-4676
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-15T04:00Z

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

General Comment:Dear Mr. Zeller:

As we have corresponded with you before, we are writing this time as two individual consumers 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 my wife and myself, we are requesting that the FDA extend the comment period for the Proposed Rule 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 us, as consumers of the products proposed for regulation under the Proposed Rule. The Proposed Rule asks many different questions that we might want to respond. We want to provide our thoughtful comments on many of these issues, but our time to devote to these important questions is limited. We have already spent many hours researching and trying to understand thoroughly these issues, but they take time. We know that the FDA took many years to even come up with the Proposed Rule, so we 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. 

We feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, we firmly believe that they saved our lives. We wish to provide you with our personal stories, as well as science- and evidence-based responses to your questions so that you can consider our comment. We realize that the FDA has the authority under 21 CFR 10.40 to extend this period and that the FDA has exercised this authority on numerous occasions in the past. We would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

We sincerely appreciate your consideration of our request, and we would be happy to discuss this issue with you further.

Respectfully submitted….