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CASAA FDA comment on UCSF FDA comment – How Public Health Policy Trumps Health and Safety

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To: U. S. Food and Drug Administration

From: Brian L. Carter, PhD and Carl V Phillips, PhD

30 September 2015

VIA REGULATIONS.GOV
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.
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