Document ID: FDA-2014-N-0189-6099
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller:

I believe that there needs to be some E-cig regulation. However I do not support it being listed in this proposal or being control under the stigma of tobacco products. The type of quality control I can agree with is : not allowing sales to minors, continued use effect studies, allowing fruit and delicious flavors, summaries of purchases made by e-juice manufacturers to ensure quality raw materials are used, inspection and regulation on e-juice mixing facilities for a maximum fee of $500 per year.

I feel that categorizing E-cigs as a tobacco, product would lead to taxation that would no longer allow people to use them instead of cigarettes. This is unfair 1)They are not cigarettes and are not made of tobacco 2) There is no evidence to support that they would lead to higher health care costs.
I also feel that the high fees in this proposal will put all small businesses out and only allow 2 major industries (the tobacoo industry and the pharmaceutical industry) to be in the market which is would result in a monopoly on the market which is in breach of Anti-trust Law and Competition Law.

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.

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