Document ID: FDA-2014-N-0189-5612
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-16T04:00Z

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

General Comment:Sunday, May 11, 2014First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period 
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On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  This is the first of several Calls to Action anticipated in CASAA's Action Plan.   (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate. 

The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments.  We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances--along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)

I.  
SUGGESTED LETTER REQUESTING EXTENSION 
YOU SHOULD EDIT AS APPROPRIATE

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. 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.

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