Tuesday, November 10, 2015

FDA Authorizes Eight New Snus Products

The FDA today granted Swedish Match permission to market eight new snus products in the U.S.  This is the first time that new tobacco products have received a marketing order via the agency’s premarket tobacco product review process.  Swedish Match demonstrated (here) that the products are “beneficial to the population as a whole including users and non-users...[taking] into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.”

The products (here) consist of loose or pouch (portion) variants of Swedish Match’s General Snus:

1.  Loose
2.  Dry Mint Portion Original Mini
3.  Portion Original Large
4.  Classic Blend Portion White Large
5.  Mint Portion White Large
6.  Nordic Mint Portion White Large
7.  Portion White Large
8.  Wintergreen Portion White Large

Swedish Match filed a modified risk application for the products in June 2014, asking the FDA to change mandated warning labels (discussed here and here).  No decision has been announced.   

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