Document ID: FDA-2014-N-0189-9993
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-19T04:00Z

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 and the lives of my husband and children who smoked combustible cigarettes. 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 am 56 years old and had smoked since I was 19, and had tried for every one of those 37 years to quit smoking cigarettes. Smoking was shown in almost every TV show and movie I had ever seen until showing smoking in media and advertising was discouraged. Each time I tried to quit, I made it as long as 2 weeks before the side effects of quitting were too much to bear. I firmly believe that I was not only addicted to the act of smoking but to many of the 4,000 toxins that the tobacco industry has been allowed (thus encouraged) to treat tobacco cigarettes with. I tried hypnosis, pills, patches, etc. and nothing worked until I tried the e-cigarette. I have been a non-smoker for over 3 years now without a single relapse to smoking cigarettes. While my experience may be better than some, I believe it is certainly more prevalent than the FDA knows. Since beginning to use e-cigarettes I have over time lowered my intake of nicotine to a very, very low level and am almost ready to go to zero nicotine liquids. This method has worked for me and my husband, who smoked 3 packs a day.

I find it appalling that e-cigarette usage is being subjected to more scrutiny than the tobacco industry, or the pharmaceutical companies whose solutions (Chantix) to smoke cessation can cause people to commit suicide either slowly or quickly, depending on the method. I am passionate about this subject because, as I repeat, the availability of e-cigarettes saved my life. Let's slow things down and use a fair and common sense approach to address the issues that need to be.

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. Please allow the world more time to fully communicate before regulation is forced without proper consideration.

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