Document ID: FDA-2014-N-0189-7222
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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.

A little over a year ago, my life was greatly improved by the e-cigarette.  I was smoking roughly a pack a day.  After purchasing a starter kit for about $50, I quit cigarettes cold turkey.  Since, I have not looked back.  I feel better, I have better health checks from my doctor and have saved money.  I gladly gave up a bad habit with the help of e-cigarettes.  I can only hope that the research completed proves to be a break thru that we need to help others in their effort to quit smoking.  It is very frustrating to think that we are willing to regulate something without the knowledge to back up the regulations.  I hope that you make every effort to do the right thing and help the health of our country.  Everyday we read articles about regulations and products that are deemed unsafe.  For example:  fluoride, sweeteners, fast food, preservatives, yet they remain on the shelf with no warning labels.  I agree there should be some regulations on the product.  This is not a tobacco product.  Let's label the product for what it is.  We may need to do further studies in the findings.  Take a look at the results and health benefits.  I agree, there should be regulations as to selling to minors, quality of e-liquid manufactures and quality in product.  Please, don't let the tobacco companies have the upper hand when dealing with a product that could possibly change the health of our nation.  Give us the right and knowledge to make a decision for our health.

I appreciate your consideration of my request and am happy to discuss this issue with you further.