To: U. S. Food and Drug Administration
From: Brian L. Carter, PhD and Carl V Phillips, PhD
30 September 2015
Comment Tracking Number: 1jz-8lf9-1nx4
Comment Tracking Number: 1jz-8lf9-1nx4
Re: Comments on ANPRM “Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products” (Docket No. FDA-2015-N-1514)
This is a comment on Docket No. FDA-2015-N-1514 (advance notice of proposed rulemaking (ANPRM), “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products”). We are concerned scientists with expertise in fields related to the proposed rule making. Carter is a member of the Board of Advisors of CASAA (The Consumer Advocates for Smoke-free Alternatives Association) and an independent consultant. Phillips is Chief Scientific Officer of CASAA.
This comment should not be mistaken for CASAA’s direct comment on the ANPRM [posted at regulations.gov at http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-1514-0385 and also appearing at http://blog.casaa.org/2015/09/casaa-comment-on-fdas-proposed.html] (hereafter referred to as “the CASAA comment”). That comment presented analysis that supported the inclusion of safety warning labels and the use of child-resistant packaging, so long as these were not inappropriately used to mislead consumers about the risks or to intentionally lower product quality. The present comment has been endorsed by the CASAA leadership, and thus should also be considered an second official comment by the organization.
In the first CASAA comment, we predicted that those who seek to discourage e-cigarette use and other tobacco products may use this as an opportunity to misuse the legitimate process of creating valid and potentially beneficial safety warnings to deliver misleading claims with the intent of lowering the appeal of these products for consumers. The present comment is intended to make that concrete by observing exactly this behavior in one specific comment that has been filed. We reiterate the observation made in the CASAA comment that if FDA were to follow such advice, it would be scientifically misleading and grossly inappropriate public policy, would increase the risk of accidental poisonings by causing consumers to dismiss the warnings on these and other products as unreliable, and unnecessarily discourage smokers from seeking low-risk alternatives.
We are taking as an example for our response the comments submitted to the FDA under this docket number by the University of California, San Francisco, Tobacco Center of Regulatory Science (TCORS) and the California Poison Control System (CPCS) (hereafter: the TCORS/CPCS comment). This comment was previously published by Professor Stanton Glantz, PhD, on his UCSF website
and appears at regulations.gov at
We expect that this is but one example of many comments from commentators with similar ideology-based political goals willing to subvert the rulemaking process in support of those goals. This is not an attempt to identify every error or weakness in the particular comment, but to illustrate the attempts to misuse this process to inappropriately demonize the products. We expect that this pattern will continue with every proposed regulation in this space and point out that FDA should not mistake political advocacy for scientific analysis, even when it is coming from the NIH- or FDA-funded academics. We wish to emphasize the contrast between the tendentious TCORS/CPCS comment and the CASAA comment, which we believe makes appropriate, reasonable, and science-based recommendations concerning the labeling and packaging of e-cigarette components and dissolvable smokeless tobacco products. The authors of the TCORS/CPCS comment are on record as opposing the use of low-risk tobacco products and have supported campaigns to dissuade consumers, including smokers, from experimenting with them (e.g., http://sanfranciscotobaccofreeproject.org/curbit-2/, https://tobacco.ucsf.edu/san-francisco-launches-e-cig-public-education-campaign).
Text from the published TCORS/CPCS document is presented throughout, indented and in italics, followed by our comments in a point-by-point analysis. The TCORS/CPCS comments are reproduced verbatim; the grammar and typographical errors appear in the original.