Document ID: FDA-2014-N-0189-35091
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-07T04:00Z

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

General Comment:Dear Mr. Zeller:

I am an individual consumer of e-cigarettes and have very strong feelings about e-cigarettes as an alternative to combustible tobacco products, which I used off and off for a period of nearly 35 years. I firmly believe that these electronic products have allowed me to move toward a healthier lifestyle and I wish to provide you with personal medical information, including medical laboratory results, in response to the current issues and questions being raised, in order to take my comments into account. 

Therefore I find it necessary to 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 (which are relevant to my medical and psychological well-being) as a consumer of products that are proposed for regulation under the Rule. Although I have already spent many hours researching these issues, the Proposed Rule asks scores of different questions for which I desire to provide personal responses. My ability and resources to comment accurately on the relevant questions does not allow me to respond effectively within the currently allocated timeline. 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 consumers and the public at large a 180 day period to submit comments, considering  the proposed legislation took almost 3 years to draft. This is my only opportunity as a consumer to provide my feedback. 

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 myself and everyone else potentially impacted these decisions,  has the opportunity to provide comment on the proposed regulations.

Thank you for considering my request.