To: U.S. Food and Drug Administration
From: Carl V Phillips, PhD
The Consumer Advocates for Smoke-free Alternatives Association
8 July 2014
VIA REGULATIONS.GOV AND COURIER
Second request for extension of comment deadline for CASAA
Previously CASAA requested 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. The text of that request is included below as an appendix, and its substance is incorporated here by reference. Subsequently, FDA granted a 30-day extension of the comment period. This is grossly inadequate for the reasons we already noted. We repeat the request that the comment period be extended to a more appropriate 180 days.
Failing that, we additionally request that CASAA be granted an extension of that length to file comments that specifically respond to the questions posed by FDA in the draft regulations.
The proposed regulations posed approximately 100 separate questions about e-cigarettes and other products that are part of CASAA’s mission. Even with the existing extension, the comment period is approximately one day per explicitly posed question. CASAA is in a unique position to be able to provide empirical answers to many of these questions. However, under the current deadline, we will only be able to comment on the affirmative content of the regulation itself and analyze its implications. While the length of the comment period is grossly inadequate even for that, we expect to file such comments according to the existing deadline. However, it will be physically impossible to respond to the requests for information that FDA claims to be interested in obtaining.
A failure to further extend the comment period would be a clear indication that FDA is not genuinely interested in obtaining scientific answers to the questions it posed.
Submitted 6 June 2014:
Request for extension of comment deadline
I am writing on behalf of The Consumer Advocates for Smoke-free Alternatives Association (CASAA) 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.
We are 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 our count, FDA asks 99 separate questions (not counting duplications) for information relating to e-cigarettes and other smoke-free products. We and our constituents (the primary stakeholders in this process) will be unable to respond to most of these under the current deadline. We believe that we can provide useful and unique information in response to many of the questions if we have sufficient time to do so. In particular, we 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 we will be able to provide detailed information from this and other research.