SS December 2015

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December 2015 SMOKESHOP 39 PROCESS BODES POORLY FOR VAPING PRODUCTS The Swedish Match PMTA application, which was over 100,000 pages long, was packed with host of scientific infor- mation tapping years of studies and history on snus—some- thing that novel new vaping products would not be able to take advantage of. It's certainly no coincidence Dr. Siegel, a professor in the Department of Community Health Sciences at Boston University School of Public Health and an outspoken critic of FDA regulation policies that he ar- gues discourage the adoption of less harmful tobacco prod- ucts, said the Swedish Match PMTA process bodes poorly for the new generation of lower risk smoking alternatives. "First, it demonstrates that successfully submitting a PMTA is a resource-intensive, complex, burdensome, and highly expensive project that can only be completed success- fully by, if anyone, the absolutely largest e-cigarette compa- nies," Siegel blogged following the FDA marketing approv- al announcement. "This is simply not something that a vape shop owner, the owner of a small e-cigarette business, or the owner of a small e-liquid business is going to have the capa- bility or resources to carry out. The FDA deeming regulations amount to a de facto prohibition of all or most electronic ciga- rettes currently on the market." Siegel said the process also demonstrates the absurdity of the FDA's regulatory approach, where combustible ciga- rettes—the most toxic consumer products on the market—are fully grandfathered, but that "much safer products such as snus and tobacco-free electronic cigarettes have to file bur- densome and prohibitively expensive applications with little technical possibility of being approved under the guidance proposed by the agency." The barriers to success approval for new, lower-risk prod- ucts are daunting, if not downright impossible to meet. "This is an insane way to craft a regulatory strategy for the range of nicotine-containing products on the market," Sie- gle continued. "In fact, it is the exact opposite of the proper approach… The safest [tobacco] products on the market— electronic cigarettes—are being forced to complete complex, burdensome, expensive, and unruly applications for which in most cases it is technically impossible to make the demonstra- tions that are required by the deeming regulations. APPROVAL COMES WITH CAVEATS "Authorization of these products is recommended so that cur- rent smokeless tobacco product users who chose to continue using tobacco products will have additional options for less toxic smokeless tobacco products, thereby potentially decreas- ing the negative health impact from tobacco product use," FDA concluded in its 67-page approval report. "It is unlikely that a significant portion of U.S. cigarette smokers will switch exclusively to these Swedish Match snus products, given cultural and population differences as dis- cussed in numerous FDA scientific discipline reviews evaluat- ing these PMTAs. It is also expected that uptake of these prod- ucts by nonusers is also likely to be very low, given that other very similar Swedish snus products currently exist and no in- crease in these product use has been reported." Vapor Nation•1/2V•Oct15.indd 1 9/22/15 10:53 AM

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