Document ID: FDA-2014-N-0189-4996
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:As an individual consumer, I am writing to request an extension of the comment period for the FDA’s April 25, 2014, Proposed Rule on deeming of tobacco products. I am requesting that the comment period for the Proposed Rule be extended by the FDA for a period of time of no less than 4 months. The approval of an extension will allow a period of slightly more than 6 months for comments.

There are a number of significant issues included and questions that are raised in the Proposed Rule.  As a consumer of non-cigar related products that are proposed for regulation, the impact of the Proposed Rule is important and relevant to me. The FDA requests comment on more than a hundred different questions and relevant topics. The Proposed Rule and the other topics raised by the FDA are important and numerous, and I want to provide my thoughts and comments on many of these issues.

The FDA, with all of its resources, has been evaluating its approach to the deeming of these impacted products for a minimum of 2 years. It appears that the Proposed Rule is lacking meaningful input from the consumer perspective. The Agency is not acting in good faith if we are only allowed 75 days to provide meaningful comment, feedback and insight after failing to include consumer representation in the formulation of the Proposed Rule.

I feel very strongly that e-cigarettes are a life-saving alternative to combustible cigarettes. I wish to provide you with both my personal story and science/evidence based responses to your questions. To do so, I require more time than the current only 75 day comment period.

The FDA has the authority under 21 CFR 10.40 to extend this time frame and that the Agency has done so on numerous occasions in the past. I appreciate your consideration of my request and I am happy to discuss this issue with you further.