Document ID: FDA-2014-N-0189-6892
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing to you 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 many significant issues and questions that are very 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. Many of which I might like to respond to, and the FDA has asked for responses to many of the issues. 

This is an enormous task as the issues are complex and require thorough review and analysis. My time to devote to researching and providing meaningful comments on these important questions is unfortunately limited.  The 75 day commenting periods fails to provide crucial time needed to provide thoughtful comments to the many issues raised the Proposed Rule. 

Additionally assessing and evaluating alternative approaches to the Proposed Rule that are compatible with the FDA’s goal also raises significant challenges. Many of the questions raised will need research, and analysis of data. And much of this information has not been made available by the FDA. All of this can not be done within the FDA’s proposed time-frame. This will lead to less than adequate responses to the Proposed Rule. 

I have already spent many hours researching the Proposed Rule- a 241 page document but all of this takes much time. The FDA had many years with which to make the Proposed Rule. Undoubtedly this time was necessary for preparing the proposed regulation. At the same time the public has only two and a half months to respond to the Proposed Rule. 

While I very much appreciate the agency’s asking the public for their input on how to best to regulate e-cigarettes I do not think it’s too much to ask to allow the public to have more time to respond to the many questions. I don’t believe it is unreasonable to allow the public only six months to comment on it in return. Plus this is our only opportunity, as consumers of these products, to provide feedback.  

I feel very passionate about e-cigarettes as an alternative to combustible tobacco. I believe e-cigarettes are a live saving device. It saved my life. Society should be celebrating this revolutionary technology because finally we now have the means to provide a product with which to significantly reduce smoking related diseases, and Cancer. 

All people who smoke should have the opportunity to try using the best products the industry has to offer. While I believe in regulation I am greatly concerned that if the public is only allowed to use too highly regulated products this will not provide the public with the best products, and solutions to reducing and even halting smoking related illnesses.  

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 understand 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 look forward to discussing this issue with you further.