Document ID: FDA-2014-N-0189-9133
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment: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 expect to file a separate comment on other aspects of the proposed regulation later.

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.

The Paperwork Reduction Act aspects of the proposed regulation indicate that FDA expects there will be a very small number of applications for e-cigarette products.  Speaking from my own experience, this would probably include only a fraction of the products that I use and that are important for me avoiding returning to smoking. 
I have used about 50 different varieties of e-cigarette liquid over the last year.  I have used at least 10 different pieces of e-cigarette hardware.  In addition, all the products I use  combine different liquid and hardware.  I would estimate that my favorite vendor sells nearly one hundred different products.
Either FDA's estimates for the number of filings under the Paperwork Reduction Act are a huge underestimate, or FDA is admitting that the paperwork burden will drive most of these products off of the market.  If it is the latter, the burden of the paperwork would fall not just on the merchants, but on myself and other consumers. 
I was able to quit smoking and not return to it because of the variety of products available.  If I had been limited to just a few products, I would have probably returned to smoking. 

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