Document ID: FDA-2014-N-0189-9986
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-19T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer and small manufacturer 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. 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. 

As a small manufacturer and consumer of products that would be affected by this regulation, there are many questions that I would like to answer. I would like to provide my thoughts and input on as many of these issues as I can, but my time for researching and writing thoughtful comments on these issues is limited. I have already spent as many hours researching and dissecting the issues as I can, but it all takes time and I work a full time job, usually more than 40 hours a week. I know these rules took the FDA years to come up with, and I do not think it is unreasonable to allow the public six months to comment on what the FDA has come up with. This is our only opportunity, as consumers or manufacturers to provide our feedback and more time is necessary to do that adequately. 

I feel strongly that e-cigarettes as an alternative to combustible cigarettes have saved my life. I would like to provide my personal story, and the science and evidence-based responses to your questions, and also how it has allowed me to start a small business in my comment. 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 the proposed regulation

I appreciate your consideration of my request and am happy to discuss this issue with you further.

-Tyler Strickland