Document ID: FDA-2014-N-0189-6961
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. 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.  My father smoked almost the entire time he was a working attorney.  He finally quit when they landed a helicopter on our front lawn in Austin to take him to the hospital with severe pneumonia.  However, the damage to his lungs was, by that time, done and he eventually died of COPD a little over a year and a half ago.  When I was young I tried everything I could to get my dad to quit smoking.  However, with the stress of his job, he simply couldn't do it.  If this technology had been around then, I like to think he would have had a better chance at avoiding the ingredients in the smoke that eventually killed him, while still being able to get the stimulant he needed to do his job.  I'll never know for sure, but I believe the possibility is strong enough that proponents of this product deserve significantly more time to respond to the proposed regulations.  I have seen firsthand the benefits these products have brought to other friends and family that are far luckier than my father to have had access to them.  Those people deserve a chance to provide you with their experiences so that a complete picture of the benefits of these devices can be made.

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.