Document ID: FDA-2014-N-0189-11394
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-19T04:00Z

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

General Comment:06/03/2014

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 request that the comment period for said Proposed Rule be extended by the for an additional 105 days, from its current 75-day period, to 180 days.

A number of significant issues and questions have been raised by the Proposed Rule, and they are important and relevant to me as a consumer of products that are proposed for regulation under the Proposed Rule. I feel that consumers have a right to provide their thoughts and comments on many of these issues, but the time we have available to devote to researching and providing thoughtful comments on these important questions is limited. 

As an individual consumer with concerns not only for my health, but the health and well being of those around me, I have spent many hours researching and dissecting these issues, and will continue to do so. The FDA took several years to even come up with the Proposed Rule, and to allow the public a mere six months to comment on it strikes me as highly unreasonable, and ethically questionable. 

As I'm sure you are aware, this is my only opportunity, as a consumer, to provide feedback regarding the Proposed Rule.  The same is true of other individual consumers, and hindering our ability to respond to the Proposed Rule by imposing such a short period of time during which responses will be accepted could be perceived as a highly biased and  unethical decision that goes against the mission statement of the organization you represent.

I feel very strongly about Advanced Personal Vaporizers as an alternative to combustible cigarettes.  They have had a very positive impact on my physical health, and have saved the life of a close family member. I would welcome the opportunity 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. We both realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame, and it is my understanding that the FDA has exercised this authority on numerous occasions in the past. I feel that it is only fair that the FDA offer the opportunity to provide comments regarding said Proposed Rule to all parties involved.

I appreciate your consideration of my request and welcome the opportunity to discuss this issue with you further.