SS December 2015

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38 SMOKESHOP December 2015 showing that these products, market- ed as described in the manufacturer's application, would result in a low like- lihood of new initiation, delayed cessa- tion or relapse. The FDA's review also determined that these products would likely provide less toxic options if cur- rent adult smokeless tobacco users used them exclusively. The marketing orders are product-specific and do not apply to other tobacco products. Going forward, Swedish Match North America is required to report reg- ularly to the FDA with information re- garding the products on the market, in- cluding, but not limited to, advertising, sales data, information on current and new users and adverse experiences. The FDA may withdraw a marketing order if it determines that the continued market- ing of a product is no longer appropriate for the protection of the public health, among other reasons. According to FDA, any companies receiving favorable PMTA marketing or- ders cannot say or imply that their prod- ucts are "FDA approved," and a com- pany must apply for—and receive—a separate modified risk tobacco product authorization (MRTPA) in order to mar- ket a product with claims of reduced ex- posure or reduced risk. Indeed, the eight General brand PMTAs that were submitted by Swed- ish Match North America on March 11, 2015, were done so in connection with the company's June 10, 2014 MRTPA for the same eight snus products. That ap- plication, which is still being considered by FDA, seeks to change or eliminate three of the four mandatory warning labels required on all cans of snus sold in the U.S. NEW PRODUCTS, OR EXISTING PRODUCT WITH MODIFICATIONS? Supply chains can be excused for their confusion over the rash of headlines touting the approval of "new" prod- ucts, since versions of the eight brands in question are already on the market in the U.S. According to the FDA, PMTA approval is not only required for entire- ly new products, but also before making modifications to a product that was orig- inally marketed and sold after Feb 15, 2007, but before March 22, 2011, which is the case with these General brands. "The factories in Sweden that make General snus have made such improve- ments and have been implemented for General snus sold in Sweden and via Internet shops, [but] they have not been implemented for the products sold over the counter in the U.S.," writes Larry Water, a reporter for In order to sell the improved products in the U.S., Swedish Match required explic- ite FDA approval via SE or PMTA. REGULATION INSIGHT > Snus production at Swedish Match's factory in Kungälv, Sweden. > The PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer's application, would result in a low likelihood of new initiation, delayed cessation or relapse.

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