Document ID: FDA-2014-N-0189-4713
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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 raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. 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. 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.  Having tried patches, Chantix, and cold turkey to no avail in attempts to quit smoking, e-cigarettes are working for me.  I've been tapering down my nicotine gradually and expect to be completely smoke-free three months from starting my e-cigarette use.  I began using my e-cigarette 7 weeks ago and have had two tobacco cigarettes in that time.  I started on 18mg/ml nicotine fluid and have since tapered to 12mg/ml.  In a couple weeks, I will taper to 6mg/ml and eventually arrive at 0 nicotine at which point I will very likely give up the e-cigarette altogether.  I am aware that using an e-cigarette is probably not as healthy as quitting cold turkey, but I can attest that it is the one thing that has worked for me in getting away from my 23-year smoking stupidity (1.5-2 packs a day these past few years).  I'm sure you probably hear this frequently.  At some point, all those reports should add up to something more than "anecdotal."  It is my belief that stories like mine give credibility to e-cigarettes as smoking cessation aids.  I've stopped smoking tobacco cigarettes, and I'm weaning myself off a lifetime nicotine addiction.  I strongly feel that over-regulating this industry will limit product availability by making it so that only large tobacco companies are able to bring products to market.  And frankly, the products they offer today are far more expensive and of a significantly lower quality than products I'm able to purchase through other suppliers.  They also don't have the best public health record or reputation for transparency, and I loathe the thought of providing them with any further revenue.

I would like to see studies performed to develop facts to enable the population to make informed decisions about the use of e-cigarettes.  With no hard science, hard regulation seems to put the cart before the horse.  I fully support supplier inspection, full disclosure of chemicals, compounds, and components, and restriction of sale to minors.