Tobacco Asia

Volume 19, Number 4

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50 tobaccoasia / Issue 4, 2015 (September/October) This could've been a rather short article if we had simply stated that currently not one single MRTP has been endorsed by the United States Food and Drug Administration (FDA) or is actively market- ed as such anywhere – and then be done with it. But we decided that approach would be too easy and also fail to do justice to a product segment that may sooner or later indeed emerge as a very im- portant new addition to the portfolios of tobacco companies in the US and worldwide. The Definition "MRTP" is of course an acronym standing for "modified risk tobacco product". While this term in itself already gives an overt hint as per the main property such a product must impart, one also has to understand that it has been coined by the FDA. In that respect it wasn't devised over the course of a lengthy marketing brainstorm at some obscure tobacco firm. There even exists an official FDA definition. According to Michael Felberbaum, a press of- ficer with FDA's Office of Media Affairs in White Oak, Maryland, MRTPs are "tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related diseases associated with commercially marketed tobacco products." He added that any person or corporate entity may submit an application seeking an order under sec- tion 911(g) of the Federal Food, Drug and Cos- metic Act (a.k.a. FD&C Act) to have their product recognized as an MRTP. The Conundrum For such an application to have any chance of approval, the product in question must therefore effectively reduce not only exposure to toxicants contained in regular tobacco but also lower the health risk associated with the consumption of cigarettes or other combustible tobacco products. And naturally enough, these claims must be backed up by rigorous scientific evidence. As the industry continues writhing to appease anti-tobacco lobbyists, national regulators, and health au- thorities alike on all fronts, MRTPs (modified risk tobacco products) may offer at least partial respite from this intensifying onslaught – or do they? A Lot of Smoke over MRTPs? Formulation lab for e-liquid development *All images courtesy of British American Tobacco By Thomas Schmid

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