Document ID: FDA-2014-N-0189-6059
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing 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 a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks so many different questions that I (and many others) will want to respond to. I want to cover many of the points regarding these regulations in detail, as well as to provide legitimate research and studies to back up my argument. However, with the 75 day commenting window, it does not give me enough time to produce a genuine comment regarding the impact of these regulations. On an issue such as this, it takes an abundance of time to devote to researching and understanding the regulations which are being proposed, and we as consumers, simply don’t have enough time to come up with a meaningful comment within the allotted time. I am aware that it took the FDA a number of years to gather these proposed regulations, and thus I would not think it unfair to give the American consumers more time to think this over, and do proper research to be able to provide a meaningful response to these regulations.

To me, e-cigarettes are an alternative which have greatly increased my quality of life, they are something that I am grateful for. With this being said I believe every consumer in the U.S. needs more time to look over these regulations and also comment they’re standpoints regarding these deeming regulations which threaten to greatly affect the devices which have helped and saved numerous lives by allowing people to quit tradition tobacco cigarettes. 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.