Tobacco Products

MRTP Application Actions (Orders, Denials, and Responses)

Submit comments on Swedish Match North America, Inc., MRTP application amendment.

On October 10, 2018, FDA posted an amendment to the modified risk tobacco product applications (MRTPAs) for General Snus products submitted by Swedish Match North America, Inc. in response to FDA's December 14, 2016 letter. The Federal Register published a notice announcing that the formal docket for public comments is reopened.

As of December 14, 2016:

Product Names and Order Letter Manufacturer Status Decision Summary Decision Date Additional Documents*
General Loose Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Dry Mint Portion Original Mini Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Portion Original Large Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Classic Blend Portion White Large - 12ct Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Mint Portion White Large Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Nordic Mint Portion White Large - 12ct Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Portion White Large Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*
General Wintergreen Portion White Large Swedish Match North America, Inc. Denial/ Response TPL001 12/14/16 Additional Documents*

* Additional documents include Environmental Assessments (EA), scientific reviews, MRTP application files, TPSAC materials, and other resources.

Page Last Updated: 10/29/2018
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