SS June 2016

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32 SMOKESHOP June 2016 I f the premium cigar industry is hop- ping mad at the FDA's new grip on its products—a category it argues is inherently different from other com- bustible tobacco products on a host of variables—that frustration pales in comparison to the disbelief of the vapor industry, which from its inception has offered a long hoped-for reduced risk alternative to combustible cigarettes. Yet FDA lumps every nicotine-containing product all together under a single regu- latory approach. It's an approach that two major va- ping trade associations argue stands in stark contrast to other governents. "Rather than pursue a responsi- ble regulatory structure for e-cigarette and vapor products, like the European Union (EU) has with its adoption of the Tobacco Products Directive (TPD), the FDA has taken the opposite path, issu- ing rules which will kill the e-cigarette category," says Ray Story, head of the Tobacco Vapor Electronic Cigarette As- sociation (TVECA). "This result is inexplicable, especially when a clear example exists of how to do it correctly," Story observes. A week before the FDA released its final deeming rule regulating e-ciga- rettes, London's Royal College of Phy- sicians (RCP), which has set standards for the responsible practice of medicine since 1518, issued a report on e-cigarettes which actually encourages their use. The RCP concluded that e-cigarette and va- por devices actually promote the public health, leading to a decrease in death and serious disease. The FDA, however, adopted a differ- ent approach. "I can't say I'm surprised," says Sto- ry, "Disappointed, but not surprised," in observing that "facts and reason fell on deaf ears" in adopting the proposed rules. Story contends that no one is argu- ing that vaping is as harmful as combus- tible tobacco. "Even Mitch Zeller, head of FDA's Center for Tobacco Products, has stated that 'nicotine is not the problem,'" says Story, pointing out the hypocrisy of the agency's actions and statements. The Smoke-Free Alternatives Trade Association (SFATA), the largest trade as- sociation representing and managing the interests of the vapor industry, is equal- ly critical of FDA's final deeming rule on e-cig and vapor regulations, which it contends essentially bans 99 percent of all vapor products on the market as a result of the February 15, 2007 predicate date. SFATA contents that the vaping indus- try has a long history of supporting "sen- sible science-based regulations," including license requirements, banning sales to minors, and adopting child-resistant pack- aging, but that the FDA's final rule "pulls the rug out from the nine million smokers who have switched to vaping." "These new regulations create an enormously cost-prohibitive regulato- ry process for manufacturers to market their products to adult smokers and va- pers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-bil- lion dollar job-creating industry, the ma- jority of which are made of small busi- nesses," SFATA adds. While Europe's approach to vapor regulation now stands in stark contrast to America's approch, TVECA's Story notes it didn't come easy. "We fought the hard battles in the courts and in the Euro- pean Parliament, and we have the scars, and victories, to prove it," he said. "This isn't new to us. We've led the charge in the past, and without our court victories over the FDA, the e-cigarette category wouldn't even exist today." SFATA says it is essential that Congres- sional action be taken so vapor products can remain on the market as highly effec- tive replacement tools for smokers, citing a growing body of scientific evidence that vapor products are more than 95 percent less harmful than combustible cigarettes. The vapor industry agrees: the only vi- able option at this time is to change the predicate date with federal legislation, so that a more reasonable substantial equiv- alency pathway to market is created. Story remains positive, "It's time that the industry consolidate behind a viable effort. I'm confident that when everyone really understands what is at stake, the path will become clear," he says. > VAPE ISSUES The FDA claims that science must guide its decisions, but as far as the vaping industry can see, the agency has put on blinders or worse, jumped to poor and premature conclusions. > STAFF REPORT Up in a Puff of Vapor

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