Document ID: FDA-2014-N-0189-10327
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-19T04:00Z

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

General Comment:Dear Mr Zeller:

I am writing as an e-cigarette user 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. While I have had some time to look into research pertaining to the proposed rules, the subject matter requires more attention that the current 105 day period does not allow for. The proposed rules are very important and relevant to me as a consumer of products that are proposed for regulation under the Proposed Rule. I have spent many hours researching these issues but require more time to prepare possible comments to this rule. 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 and firmly believe that they saved my life. I wish to provide you with my story, as well as science and evidence based responses to your questions so that you can take my comment into account. 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.