Document ID: FDA-2014-N-0189-6386
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I am personally requesting that 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 be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

I am an individual consumer of the electronic cigarette products mentioned in the Proposed Rule and thus have a personal interest in having enough time to reply.  

The Proposed Rule details out many significant issues that may impact my ability to remain a non-smoker should the Proposed Rule go into effect as written. 

The Proposed Rule contains numerous questions that are important and relevant to me as a consumer of electronic cigarette products, I want to address each question as fully and thoughtfully as possible. 

I have spent many hours researching and mapping these issues against current regulations, however doing so takes a great deal of time. 

I am aware that the FDA at their liberty created the Proposed Rule over the course of many years, I believe it only fitting to allow me six months to formulate thoughtful comments and answers to it. This is my only opportunity, as a consumer, to provide my personal feedback. 

Electronic cigarettes have been instrumental in my successful effort to quit use of combustible tobacco, I strongly believe the availability of this product has saved my life.

My personal story in brief is one of being a traditional smoker of 1.5 to 2 packs of cigarettes a day for 30 years, on my introduction to electronic cigarettes I had 9 packs of cigarettes in my possession which I will never light thanks to the electronic cigarette.  My desire to quit combustible cigarettes has been a long and difficult one, I have used every available OTC and prescription product available to me without success.  My repeated failures had me terrified that I would die from my smoking addiction.  I do not fear that I will die prematurely now thanks to the electronic cigarette, my ability to breath freely is so greatly improved now that I no longer wake gasping for air.       

I realize that the FDA has the authority under 21 CFR 10.40 to extend the public comment time frame and that the FDA has exercised this authority on numerous occasions in the past. I am personally asking that you do so now so that I and all whom have similar interests in electronic cigarettes have the opportunity to provide comments and answer the questions in this proposed regulation.

Thank you for considering my request, I am more than happy to discuss my concerns with you further.

Maurice F. Pudlo II.