Document ID: FDA-2014-N-0189-6906
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 believe that e-cigarettes are a safer alternative to combustible cigarettes. I also understand the need to confirm the relative safety of e-cigarettes; more specifically, the need to determine the relative safety of e-juice (containing nicotine) through scientific inquiry and experimentation; as well as through reference to published studies that are deemed pertinent to the issue of e-cigarettes and the relative safety of e-juice (containing nicotine). 

I would like to add a few words regarding my own experience. 

I quit smoking combustible cigarettes approximately four years ago and adopted an e-cigarette as an alternative. I mix my own "e-juice", which is a mixture of Vegetable Glycerin, Nicotine (including Vegetable Glycerin), flavor extracts and distilled water. I have reduced the amount of nicotine I add to the mixture from 24mg per ml to less than 4mg per ml. I anticipate that I will have completely freed myself from nicotine by the end of the current month (May of 2014). 

These are the points I wish to emphasize. 

1. The ability to control and account for the ingredients in the e-juice is an advantage over traditional combustible cigarettes.

2. Having control over the nicotine content of the e-juice (expressed in mg. per ml.), allows one to gradually reduce the amount of nicotine one consumes with the eventual goal of stopping the use of nicotine altogether.

3. Making use of an "e-cigarette" device to vaporize a liquid that does not contain nicotine is my goal. Once the nicotine is taken out of the equation, what interest could the FDA possibly have in this example?

It is my opinion that the availability of e-cigarettes has decreased the probability that I will suffer from a smoking related malady. Over the last four years, I have been less prone to lung infections, and in general feel healthier than I did when I was smoking combustible cigarettes. I will not say that e-cigarettes have saved my life. I will say that e-cigarettes provide a safer alternative to combustible cigarettes, as well as an apparently valid method for quitting nicotine altogether. This is the point I am most concerned about. If one takes nicotine out of the equation, it is not clear how vaporizing and inhaling Vegetable Glycerin mixed with a flavor extract requires the attention of the FDA. In short, one who has quit nicotine but continues to use an "e-cigarette" should be considered a separate class, and regulations pertaining to nicotine usage should not encumber those of us who are not ingesting it. This is just another way of saying that the devices (the "hardware") that can be used to vaporize a liquid by means of a resistance coil should not be regulated in any manner whatsoever, since it is the e-juice that contains the chemicals of interest to the FDA. In fact, calling the hardware device an e-cigarette is misleading. The device is a vaporizer, and it is not limited to one and only one purpose; that is, unlike a tobacco cigarette. Regulating the device is akin to regulating paper simply because one can use paper to wrap a conventional tobacco cigarette. This is not sensible.  

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 willing to discuss this issue with you further.