

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

General Comment:To:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
RE: Docket No. FDA- 2014-N-0189
 
RE: "Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act," Docket No. FDA- 2014-N-0189 request for extended comment period.
 
Dear Director 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. 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.
 
As a consumer of the electronic cigarette, I have completely stopped use of tobacco products. Not only does it prevent the inhalation of carcinogens, but is also more environmentally friendly and has been suggested by my primary care physician as a significant improvement from tobacco use. Harm reduction is a common practice for addictions. Nicotine is known as an addictive substance however it is the method of administration that causes so many health concerns. By cutting out the toxic route of delivery, the risk is insignificant. I smoked cigarettes for 31 years and last year switched to the electronic cigarette and after many attempts at trying to quit over the years, this has been the only method that has been successful for me. If these became unavailable, I am certain that I would turn back to tobacco products. Prior to the switching to “vaping” my lung function was horrible but over the past year, according to my doctor, my lungs have significantly healed and I am able to do a lot more physically. The idea of banning these electronic cigarettes could be the difference between life and death for many people including myself.
 
I thank FDA for the opportunity to provide my views on the proposed rule.

Sincerely,


Kathleen Falcone

