Document ID: FDA-2014-N-0189-6525
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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. While there are many questions raised in the Proposed Rule, my time to research and fully prepare responses is meager. I strongly feel that at this critical juncture in the development of regulations, time should be allowed to make the best, most thoroughly considered decisions about what is best for the huge number of former smokers who use these to reduce harm and the even larger numbers of current smokers who may in the future. These devices have shown bright promise toward curtailing a public health danger. I know that the FDA took many years to draft the Proposed Rule, and, in light of the huge public health promise of these devices, I do not think it is unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback before the framework that will shape this promise is enacted. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, they allowed me to quit smoking after 38 years. This is an amazingly effective harm reduction strategy which offers many the freedom from the carcinogens found in tobacco cigarettes. 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.