Document ID: FDA-2014-N-0189-8620
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.

These rules greatly impact me as I am a consumer of e-cigarette products which have helped me quit a 10 year deadly tobacco habit.  There are many proposed rules and I do not believe 75 days is ample time for myself or the vaping community to intelligently and accurately respond to the FDA's proposed rule.  This community has regulated itself without the FDA or any government interference for many years and if we are given the time you will find a very health conscious group of consumers that spend a lot of time doing research on these products.  I have seen many dishonest vendors put out of business in a matter of days due to the commitment of the community in keeping this tobacco alternative as safe as possible.

This tobacco free alternative could very well end up saving my life.  I am not against keeping these products away from persons under the age of eighteen or labeling the products as addictive.  However there are so many other points to your proposed rules that with a full time job and attending college courses there is no way people like me will have time to comment in only 75 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.  If all of these products are banned at once because they do submit the required applications this will drive many people back to deadly tobacco products.  Some of these vendors are part of very small businesses, some are doing these things as private citizens.  This is how the industry has moved forward and become far safer than it was years ago, small businesses that have pioneered and listened to the community when creating products.  Some of these rules will destroy that ingenuity and destroy this rising industry.

Please give us the time we need to research the proposals and make educated and informed comments on the FDA's proposal.  I appreciate your consideration of my request and am happy to discuss this issue with you further.