Document ID: FDA-2014-N-0189-8205
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.

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 am very passionate about e-cigarettes as an alternative to the traditional combustible cigarettes. Quite simply, I firmly believe that they saved my life.  Once I ventured in to the world of vaping, I never looked back.  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.

This morning I saw you on my local fox news speaking about the proposed regulation.  I did take note on how you commented on most people that use "e-cigarettes" still use combustible cigarettes.  This could be true but I believe there are a lot of poor products on the market which very well can cause consumers to not completely remove tobacco cigarettes from their lives.  The classic cigarette style just does not do justice in my eyes.  I am worried that some of these regulations will remove great products and companies from the market.  Almost all of the devices are made basically the same.  They use different metals for conductivity.  Why should one submit a product to be reviewed by the FDA when the last device was technically the same?  I don't see the reason and logic.  This will be very costly for these small companies.  If many of these businesses can't afford to do this they will fold or sell to larger or even big tobacco companies and i believe that they will do with out these types of products and continue producing poor devices which can cause consumers to give up and many could go back to smoking cigarettes again.  I thought we would like people to get off tobacco cigarettes if they would like to.  This is supposed to be a free country and vaping is something I choose to do.  Is there a risk?  Sure, everything comes with a risk.  I feel there is no possible way e-cigarettes will harm someone as much as cigarettes will.  On the fox news interview I saw today, you stated the FDA whats to protect us, the consumers.  Again, this is a choice I made like many others.  I agree warning labels need to be added to products and sales to minors should have NEVER happened in the first place.  I want to see those rules put in place.  
My wife had smoked cigarettes for about 20 years.  Over a year ago I purchased a couple cig-a-like e-cigarettes from the gas station for her.  She did not like it at all so she kept smoking cigarettes.  For that style of product they are probably just not good between battery life and taste.  I myself did not like the product.  Months later I purchased her an "Ego" styled device which has a tank for re-filling the liquid and since then she hasn't looked back.  This is huge.  I never thought she would finally kick the habit and I am extremely happy for her.  She feels great, I feel great, to me the products we use has changed our lives in a great way.  We have both been lowering the nicotine levels in our e-liquid.  I am very low now and am close to be using 0mg nicotine e-liquid.  When this happens how am I using a tobacco product?  Also, not all nicotine is derived from tobacco plants.  When not, how is it labeled a tobacco product?  The government claims they want build small buisness so please lets keep doing this.

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