Document ID: FDA-2014-N-0189-6377
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Dear Mr. Zeller;

I am writing to you, as both an individual consumer and as someone working in this industry, 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 and my business, 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, and to both my wholesale and retail personal vaporizers and eliquids businesses. The Proposed Rule asks about a hundred different questions I might want to provide my thoughts and comments to, but as a small business owner, the time I can 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 as it took the FDA time to ask the questions, it will take time to respond responsibly. Since it is common knowledge that the FDA took many years to document their Proposed Rule, fairness to the people affected should reasonably allow the public six months or more to comment. This is our only opportunity, as consumers, to provide our feedback. 

I feel very strongly about allowing smoking adults the option to choose electronic cigarettes as an alternative to combustible cigarettes. Quite simply, I honestly believe that they saved me a life-time of smoking-related medical expenses and a healthy extension to my life. My two partners feel the same way and we hear testimonials every day from clients and customers who feel better now, after vaping for a few months, than they have in years, often decades. Given the time, I could provide you with our personal stories, as well as science- and evidence-based responses to your questions so that you can take my comments 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.