Document ID: FDA-2014-N-0189-8212
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment:Dear 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 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 asks about a hundred different questions I might want to respond to and I am not familar with regulation comment and documentation. It will take me more time yet this is my only chance for me to be heard, so it's important for me to do so. 

I am concerned that the Proposed Rules appear to eliminate the majority of small and medium business'. I don't feel the impact to the economy is easily asorbed since most of the large companies do most of their work overseas. They do not operate store fronts and they are not customizable. I tried a kit I bought at a convience store and it didn't work for me. That stalled my attempt to consider trying again for another 2 years. Then I visited a store, they were able to listen to my needs, get my flavor profile and instruct me on how to use their products. They were available if I had more questions and I remain in contact with them today. The store opened up in a nearly abandoned strip mall and have been able to expand twice within the last 2 years. There is now a small coffee shop and a couple of other small business that didn't use to be there. 

But most of all, I am concerned about lack of product choice. I believe it is the wide array of customizable product in all colors and flavors that make not smoking possible. I'm afraid if that were eliminated I would probably go back to smoking. As I stated above, the early products weren't much help. It took trial and error in my local store before I found one that I could do and knew would work for me. I also find I use multiple levels of nicotine per day in order to keep it lowest. 

Statics show 70% of smokers WANT to quit. I think that is true and I think the FDA fails to take into account that most people do NOT want to smoke. If I had reason to think my addiction was getting worse, I would stop the product immediatley. I think that is common sense and my nicotine levels have decreased. There is a transition since it is different. That also tells me I am breaking the chain of addiction even further. Flavors remove me even further from cigarettes. 

I would hate to see combustionable cigarettes rise again in response to the limitation of products that the HHS Economic Anaylisi tends to imply will happen and I think that is a real possibility. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. 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. I would therefore ask that you do so here, 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.