Document ID: FDA-2014-N-0189-5420
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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.

E-cigarettes must be better than smoking tobacco and as a result of using the vaporizer for nearly 6 months I feel better in my health, I feel that my breathing is better than it has been in the past 10 years as a smoker and I generally feel better in myself that I have given up tobacco products after years of trying different things (nicotine tablets, patches) which none worked. Now I cannot stand the smell of tobacco cigarettes after quitting with the e-cigarette. There has to be an extension to the 6 months that has been given for people to give their opinion. I believe that that e-cigarettes have helped me quit a habit of 10 years and for certain regulations to be set against e-cigarettes is not the way forward. At most I do believe that there should be tighter restrictions to who can buy them and with that said as it has helped me quit tobacco it could help the many underage smokers that there are out there. These regulations need to be reviewed and discussed with by the users of the product just as much as the FDA do. It would be a shame to put regulations on a product that gets people of the tobacco products. I wish I used the e-cigarette earlier.

Please extend the comment period for the full 105 days and consider all comments and views

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