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. The Federal Register will publish a notice when the format docket for public comments on the amendment is reopened.

As of December 14, 2016:

Product Names and Order LetterManufacturerStatusDecision SummaryDecision DateAdditional Documents*
General LooseSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Dry Mint Portion Original MiniSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Portion Original LargeSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Classic Blend Portion White Large - 12ctSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Mint Portion White LargeSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Nordic Mint Portion White Large - 12ctSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Portion White LargeSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*
General Wintergreen Portion White LargeSwedish Match North America, Inc.Denial/ ResponseTPL00112/14/16Additional Documents*

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

Page Last Updated: 10/10/2018
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