Document ID: FDA-2014-N-0189-11637
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. 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.

As a smoker for 8 years and a person with Fibromyalgia and Chronic Fatigue syndrome, smoking was a way for me to get energy and deal with pain. But at the same time, I’m slowly killing myself and negatively impacting my health. I never thought I could quit, and have no intention to quit at the time when I picked up the ego-twist (a personal vaporizer for e-liquid), I just thought it’d be a good way to maybe reduce the amount of cigarettes I smoke each day and to save some money. 2 weeks later I’m cigarette free and have not missed a cigarette since May 1, 2014. I tried blue e-cig before which doesn't help. I tried those other e-cig from vendor in the mall which doesn't help. But the combination of a good vaporizer and e-liquid I’m again in control of my health. I don’t suffer from nicotine withdrawal even though I’ve cut my nicotine content of my e-liquid from 18% to 8% in just a month. When I’m dealing with extreme Fibromyalgia pain, picking up my vaporizer helped me to regain my ability to focus and function. To me personally, e-cig/vaporizer has saved my life. Of course there are more details in regards to my story and research that I know of that can further support my point. But stated above, there’s just not enough time to make a good detail comment with just a 75-day period.

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