Document ID: FDA-2014-N-0189-57919
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-31T04:00Z

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

General Comment:I am writing 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.  CASAA is a public health and education NGO, and is the leading representative of consumers who use or might choose to use low-risk smoke-free tobacco/nicotine products, including e-cigarettes which are a key component of the proposed regulation. 

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. 

FDA spent years compiling the proposed regulations and associated documents, which total 300 to 500 pages (depending on what documents are considered associated).  It is unreasonable to expect the public to be able to comment on them in a mere 75 days.  That short time period ensures that only large corporations will have the resources to comment substantively on much of the content.
The proposed regulation and associated documents are dense with scientific claims.  We have found that it takes approximately half a person-day per relevant page to review and prepare comments on those claims.  This is over and above the analysis required by the core issues of impact on consumers (which we have already partially commented on in the context of the Paperwork Reduction Act) and other consequences of the proposed regulation.

By CASAA's count, FDA asks 99 separate questions (not counting duplications) for information relating to e-cigarettes and other smoke-free products.  CASAA and their constituents (the primary stakeholders in this process) will be unable to respond to most of these under the current deadline.  I believe they can provide useful and unique information in response to many of the questions if they have sufficient time to do so.  In particular, they are prepared to launch a survey of U.S. e-cigarette users designed specifically to answer many of FDA’s questions.  If we obtain the requested extension they will be able to provide detailed information from this and other research.