Document ID: FDA-2014-N-0189-42530
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-11T04:00Z

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

General Comment:May 18, 2014

Dear Mr. Zeller:

I am writing as an individual consumer and a healthcare provider 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 and my patients regarding products that are proposed for regulation under the Proposed Rule.  I want to provide my thoughts and comments on these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited.  The enabling law has several points that may or may not be applied and the consequences of their application must be weighed carefully in consideration of my proposals.  I realize that the FDA required a long time to develop these proposals, involving several adjunct resources.  As this is the only time consumers of e-cigarettes will have to comment, asking that the comment period to be extended is a reasonable and necessary request.

As a healthcare professional I have seen the damage done by combustible tobacco products. I have also seen the tears of joy on the faces of patients who discovered e-cigarette use as a way out from under the crushing consequences of nicotine addiction.   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. 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. Please do so again, 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.

Respectfully,

Robert Bruce Nye, RN
Papillion, NE  68046
Email:   rbnye@cox.net