How might FDA fix this e-cigarette PMTA mess? Commentary on Glantz and Lempert and Meshnick et al

In their articles critiquing the US Food and Drugs Administration’s (FDA) first marketing order to allow the legal marketing of any e-cigarette, for Vuse Solo tobacco-flavoured e-cigarettes, Glantz and Lempert and Meshnick et al discuss a range of serious procedural, technical and substantive problems with FDA’s publicly released explanation of how its evaluation of the Vuse application supports that order as appropriate for the protection of the public health.1 2 Those problems are too numerous to list here, but Glantz and Lempert and Meshnick et al reasonably conclude that FDA should withdraw its order allowing the marketing of the Vuse Solo e-cigarettes because the agency did not adequately evaluate the Vuse Solo application, did not establish that allowing its marketing was ‘appropriate for the protection of the public health’, and did not structure its final pre-market tobacco product application (PMTA) order to avoid increases in...
Source: Tobacco Control - Category: Respiratory Medicine Authors: Tags: Open access Commentary Source Type: research