Document ID: FDA-2014-N-0189-8237
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 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 started smoking around the age of 18, and I smoked for approximately 32 years. Despite numerous attempts to quit by using the patch, gums, Wellbutrin, Chantix, and inhalers, nothing stuck for me. In 2012, I was to the point where I was simply trying to lessen the damage by retrohaling cigarette smoke through my nose in order to get the nicotine without inhaling into my lungs. At that time, my son suggested trying an e-cig. Having nothing to lose other than the $50 I would spend on them, I ordered a starter pack from a large company. And guess what... it worked! I was able to take in nicotine without all of the harmful tars and additives that are present in cigarettes. It was the answer to my issue. 

In a few short months, I realized that I needed something that provided a more satisfactory vaping experience, and I started using an eGo battery and a small tank that I would fill with the nicotine juice. I did that for about a year before buying a "mod" that provided variable voltage and wattage, again increasing the enjoyment of the experience. 

I have now been cigarette free for almost two years, and I feel better than I have in a long time. I no longer get respiratory infections. I no longer have that smoker's cough. I teach group exercise classes! I have my life back! 

Also...I've found that as time has gone on, my need for nicotine has lessened. I started at a 18mg (1.8%) solution, which is considered "strong." I'm now vaping a 6mg (.6%) solution. From 18mg to 6mg. And I didn't even try to lessen it. It just happened. I know many people that have gone from 24mg down to 0mg. All without even trying. That, sir, is an amazing thing. 

I understand that some restrictions have to be in place to insure the safety of everyone, and that companies are putting out products that won't harm anyone. But I also feel that the industry does very well in policing itself. If a person walks into a vape shop, they're going to be met by someone who has been where they've been and has their best interest at heart. They're going to direct that person to an alternative that will be safe and better provide a quality vaping experience. In my opinion, I would suggest focusing your attentions on the "cig-a-like" options that are often made in China and sold in gas stations. Let the small independent "boutique" proprietors do what they do without excessive regulation and fees. It's just good business.

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