Document ID: FDA-2014-N-0189-5386
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing as an interested party 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, the concerned wife of an e-cigarette consumer, 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 person affected by the products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions that I, any thousands of others like me, may want to respond to. I would appreciate the opportunity to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but this takes time. I know that the FDA took many years to even come up with the Proposed Rule, so I believe it is reasonable to allow the public the appropriate time frame within which to comment on it. This is the public’s only opportunity to provide what is certain to be valuable feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I firmly believe that these products are going save my husband’s life and will reduce the significant and proven risks to my children and myself from secondhand cigarette smoke. 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 knowledge and experience 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.