Document ID: FDA-2014-N-0189-5208
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 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 about a hundred
different questions I might want to respond to. I want 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 they take
time. I know that the FDA took many years to even come up with the Proposed
Rule, so I do not think it is at all unreasonable to allow the public a mere six
months to comment on it. This is our only opportunity, as consumers, to provide
our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible
cigarettes. Quite simply, I have seen great improvements in my health since
I quit smoking cigarettes a year ago. My doctors (Cardiologist and family
practitioner) agree that my health has improved considerably. 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.