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··~ lz~ . DEPARTMENT OF HEALTH & HUMAN SERVICES 

Food and Dmg Administration 

Center for Tobacco Products 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

November 10, 2015 

MARKETING ORDER 

Swedish Match North America, fuc . 


Attention: Gerru·d Roerty, Jr., Vice President, General Cmmsel & Secretru.y 


Two Jru.nes Center 


102 1 East Cru.y Street, Suite 1600 


Richmond, VA 23219 


via Certified Mail 

FDA Submission Tracking Number (STN): PM0000017 

Dear Mr. Roeliy: 

The Food and Dmg Administration (FDA) completed the review ofyour Premru.·ket Tobacco 


Product Application (PMTA) submitted under section 9 10(b) of the Federal Food, Dmg, and 


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


Applicant: Swedish Match North America, fuc. 


Tobacco Product Name: 1 General Wintergreen Portion White Large 


Tobacco Product Category: Smokeless Tobacco 


Tobacco Product Sub-Category: Pmtioned Snus 


Package T ype: Plastic Can 


Package Quantity: 24.0 g 


Characterizing Flavor: Wintergreen 


Portion Count: 24 pouches 


Portion Mass: 1000 mg 


Portion Length: 34 mm 


Portion Width: 18 mm 


Portion Thickness : 5.5 mm 


2 4 Tobacco Cut Size: (bll l 

(b)(4) ~ 

L-----------------------------------(b)__> __ ~: ----------------------~ 

Based on our review of your PMTA, we fmd p ennitting the new tobacco product specified 

above to be marketed is appropriate for the protection of public health, and tha t you have met 

the other requirements ofsection 91 0( c) ofthe FD&C Act. Under the provisions of section 

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 conunercial name used in commercial distribution 

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

cut size caru1ot be represented wrtli a smgle value an coiTesponding range limit. 
	

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