Document ID: FDA-2014-N-0189-5129
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment: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.

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate. PLEASE DO ADDITIONAL RESEARCH BEFORE MAKING ANY RULING.

http://onvaping.com/the-ultimate-list-of-studies-on-e-cigarettes-and-their-safety/

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. 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 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.