Document ID: FDA-2014-N-0189-4911
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Mr. Zeller:

As a consumer of e-cigarette products I am requesting that the FDA extend its comment period for the 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 request 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. We've discussed the Proposed Rule extensively online and realized that it asks far too many questions to respond to within a 75-day period. Because of my occupation, family constraints and other limiting factors, I feel that 75-days is far too short a time frame to construct a reasonable response. Given that the rules will have a long-lasting and perhaps negative impact on a burgeoning industry that is saving lives, at least a 180-day extension would allow for a more constructive discussion. I repeat, we need at least 180-days - twice the allotted time frame that the FDA has proposed.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. In short, they are saving lives. Literally, they are saving people's lives. This is not a matter that I take lightly. 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.

Sincerely,

Kannon Yamada