

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.

I would also like to emphasize that I strongly support reasonable regulations regarding all electronic cigarette products to ensure that Americans have access to the safest products possible. However I do have some concerns with a few points in the legal language regarding hardware approval and the chilling effects on innovation and small business potentially putting e-cigs largely in the hands of big tobacco who we know have a long history of dubious ethical practices.

Anecdotally, vaping has improved my health dramatically and my doctor wholeheartedly agrees. Some have been able to get away from nicotine altogether, while I, for the time being, rely on e-cigs as a much safer alternative to smoking. I am also a hobbyist and do some device engineering at my home as well as mixing my own flavored nicotine fluids. I would be destitute if new regulations prevented me from this current practice and am afraid these FDA proposals could lead to a situation that could drive me back to smoking. A very thorough, deliberate analysis and discussion is in order.

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

Best Regards,

Robert Love
