Document ID: FDA-2014-N-0189-5565
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 started smoking when I was 12.  I followed in my parents footsteps.  I didn't do it because of advertising, but rather, because it was seen to me as a natural thing that people just did.  I smoked Marlboro Menthol for 17 years.  I was a rather heavy smoker at 2 packs per day.  I'd tried several times over the years to quit using everything out there.  Gum, prescriptions, patches.  Nothing worked.  I ended up eventually stumbling upon e-cigarettes and thought why not.  Worth a shot.  The very day I got mine - I quit smoking cigarettes.  It has now been 4 years.  I have yet to touch a single cigarette.  I have no desire to either.  I started with 18mg e-liquid and have worked my way down to 6mg e-liquid.  I continue to lower my nicotine levels every so often with the goal of stopping completely.  My doctor has noticed a drastic improvement in all aspects of my health.  Especially my breathing.  I am now able to run again.

I see a lot of media reports saying that fruity flavors are only for kids.  This is simply not true.  I myself have been using a Peach flavored e-liquid because I don't want to be reminded of the taste of tobacco.  It's nasty.  I buy my liquid from a local brick and mortar shop, which by the way, has always carded people and had a sign up stating 18+.  I'm not saying that they all do.  Just stating the fact there are responsible vendors who very much support that part of regulation.

I do agree and support regulation of e-cigarettes.  I do believe they should be banned for under 18 year olds.  But I also believe that over regulating something just because you can doesn't mean that it should be done.  E-cigarettes are saving lives.  They saved mine.  I always see reports stating that there just isn't enough evidence.  One only need to look at the thousands and thousands of stories stating otherwise to find this is just not the case.

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.