Document ID: FDA-2014-N-0189-8649
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

Comment Info: =================

General Comment:Reference:
Food and Drug Administration 
21 CFR Parts 1100, 1140, and 1143 
[Docket No. FDA-2014-N-0189] 
RIN 0910-AG38

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.

I would like to explain my passion about, and where I fit into, this industry. I am 55 years of age and started smoking at a very early age. I smoked for 41 years until a year ago this past April. For those 41 years, I can’t tell you how many times I tried to stop smoking, and how many methods and products I tried with no success. I finally reached the point of concluding I would go to the grave being a smoker. This new product, Electronic Cigarettes, I saw as a new plan and was very suspect of having any success. Well, it’s been over a year now of being off traditional tobacco products. My health has greatly improved and my doctor is shocked, as is my dentist. Both tell me keep it up. I have increased my lung capacity and am doing things now that just a year ago I would not or could not even consider doing, like kayaking the beautiful north Idaho rivers. I am totally convinced this product and industry have given me an extended life by providing me an alternative to traditional tobacco. Over the past year of using these products I have been able to reduce my nicotine from 24 milligrams (mg) per milliliter (ml) to down to 6 mg per ml. My wife, who was a smoker for these many years, has been able to get to 0mg nicotine. This product has great success with the advanced devices that are available through the many small, independent stores throughout our wonderful state. 

As for the proposal, I am very concerned at its aim and the direction it is proposing to take with this wonderful, life-extending product. This industry has spread very fast, I agree, throughout the USA; and rightly so.  Many individuals are as passionate as I am about this product. These are people that have been trapped by big tobacco products for years, products that have taken many lives and provide little to help people to get off tobacco. Electronic Cigarette small business owners encourage the opposite in the way of harm reduction through the use of these products.

The proposed regulation and product approval processes that it outlines are totally unrealistic for any of the small businesses that have created this industry and caused it to grow to such levels today. To meet these over-reaching demands of product approval fees would be the death of the small business, and a total turning over of the industry to those that have caused such concern in this country and the world in the first place. The pre-existing products of 2007 of this proposal are not even what the market today is thriving with as productive product for use. The FDA claims this is a way for existing companies to bring their products to market under this proposal. It’s poorly researched on the part of the FDA if they truly believe this. Many of the pre-existing products of 2007 do not even exist in the industry today. 

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. 

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.