Document ID: FDA-2014-N-0189-5139
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Dear Mr. Zeller:

I am writing you as a small business owner. I am concerned with your proposed rule regarding electronic cigarettes. I have thousands of Customers who would testify to the benefits of replacing their long term cigarette habit with e-cigs. Moreover, they would testify that their success has been largely due to the advanced custom products and tasty e-liquid flavors that specialty shops offer as opposed to what one might find in a convenience store. I am afraid that if you implement this proposed rule, that you will effectively wipe out all of the effective products currently on the market. (For example, just for my 1 line of juice I would have to submit 250 applications to you for approval. The cost of this could be millions of dollars with no guarantee that any of them would even be approved.) This will only leave room for the large companies who make the products that are far less effective and desirable. Big Tobacco and Big Pharma have already proven that they do not have the best interest of the people in mind, and I believe that this will only make that problem worse. It is my opinion that e-cigarettes should not only be embraced, but they should replace tobacco completely. If you really want to save lives, this is one idea that would accomplish that almost instantly. 
I am requesting 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 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.
Respectfully,
Jason Bench