

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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to call for an extension of the comment period for the Food and Drug Administration's 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 several significant arguments 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 makes many points that I might want to respond to, but only after thorough investigation. 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 never start using a product without first doing my own analysis on the safety of what I am consuming. I have already spent many hours researching and dissecting these issues and the all around safety of the products in question, but taking that informed approach is time consuming. 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 on a product that we believe has saved our lives. 

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they are prolonging my life and improving the lives of my loved ones. 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.

- Karl Rudl
  
