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.....~.10 8~ DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 

Center for Tobacco Products 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

November 10, 2015 

MARKETING ORDER 

Swedish Match N01ih America, Inc. 

Attention: Gerard Roe1iy, Jr., Vice President, General Counsel & Secretmy 

Two James Center 

1021 East Cmy Street, Suite 1600 

Richmond, VA 23219 

via Certified Mail 

FDA Submission Tracking Number (STN): PM0000010 

Dear Mr. Roe1iy: 

The Food and Dmg Administration (FDA) completed the review of your Premarket Tobacco 

Product Application (PMTA) subinitted under section 910(b) ofthe Federal Food, Dmg, and 

Cosmetic Act (FD&C Act), for the following tobacco product: 

Applicant: Swedish Match N01ih America, Inc. 

Tobacco Product Name: 1 General Loose 

Tobacco Product Category: Smokeless Tobacco 

Tobacco Product Sub-Category: Loose Snus 

Package Type: Cardboard Can with Plastic Lid 

Package Quantity: 45.0 g 

Characterizing Flavor: None 

Tobacco Cut Size:2 (b)(4)

(b)(4) 

f>H4l 

Based on our review of your PMTA, we find pennitting the new tobacco product specified 

above to be marketed is appropriate for the protection ofpublic health, and that you have met 

the other requirements ofsection 910(c) ofthe FD&C Act. Under the provisions ofsection 

910, you may introduce or deliver for introduction into interstate commerce the new tobacco 

product specified above with the enclosed labeling. 

1 Brand/sub-brand or other commercial name used in commercial distribution 

2 The applicant provided 4 (b)( ) to characterize the tobacco cut size. Therefore, the tobacco 

cut size cannot be represented wtth a smgle value and cotTesponding range limit. 
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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