Without a real cessation benefit there is no benefit to trade off against the millions of kids e-cigarettes recruit to nicotine addiction. More important, FDA continues to ignore the fact that much newer studies in the real world based on actual effects of e-cigarette use on cigarette cessation among consumers show no population cessation benefit of e-cigarettes. For example, “Thus, CC smokers who choose to use the new products may experience the benefits of significantly reducing their nicotine exposure, reducing their exposure to BOE (see Section 3.5.1.2.), reducing their nicotine dependence, and facilitating smoking quit attempts and success” (page 23).įDA’s speculation that Logic users reduced CPD will lead to cigarette cessation is based on a single literature review based on research published as of November 2004, 18 years ago and years before e-cigarettes were on the market. This is all the more stunning because JT/Logic does not present information in its application to make this case, something FDA recognizes:īecause reductions in CC consumption are other found to increase the likelihood of successful CC cessation ( Hughes & Carpenter, 2006), decreases in CPD associated with the use of the new products may promote CC quit attempts and lead to successful CC cessation among CC smokers who are interested in quitting however, these outcomes are not assessed in the current PMTAs.” (page 6)įDA repeats this argument many times in its report, never citing any specific evidence presented in the application or the current scientific literature to support its conclusion. FDA argues the Logic products will help smokers quit even though Logic makes no such claims While JT/Logic does not address youth use at all even though the law specifically requires FDA to consider effects on nonusers, FDA did it for them, concluding that because tobacco flavor e-cigs are not as popular as flavored e-cigs (ignoring menthol), youth use was not a problem.Īs with Vuse Solo, FDA concludes, “The potential of the new products to benefit smokers who significantly reduce their CC use (or who switch completely and experience CC cessation) outweighs the risk to youth …” but, as with Vuse Solo, does not give any numbers about just how many kids FDA is willing to sacrifice per adult beneficiary.While JT/Logic specifically says “that the new products are ‘designed for adult combusted tobacco smokers, and their user guides state that the new products are not smoking cessation products ” and makes no such claims in the application, FDA concludes that the products are “appropriate for protection of public health” because they will help some smokers to quit.Specifically, to justify authorizing the Logic products, FDA advanced arguments that JT/Logic didn’t make itself, most notably: It shows even more serious problems than when FDA bent over backwards to authorize RJR’s Vuse Solo. ![]() ![]() Thanks to my colleague Lauren Lempert filing a Freedom of Information Act request, we now have the TPL. ![]() FDA withheld the Technical Project Lead (TPL) report that provides the scientific justifications for its decision. ![]() On MaFDA authorized the sale of three electronic nicotine delivery systems distributed by Japan Tobacco’s US company Logic Technology Development, – two conventional e-cigarettes and one heated tobacco product.
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