US FDA reviews updated application for Swedish Match General smokeless tobacco products

The FDA is conducting a scientific review of an updated Modified Risk Tobacco Product application for General smokeless tobacco products submitted by the U.S. subsidiary of Swedish Match.

According to an update posted on the official website of the U.S. Food and Drug Administration (FDA) on November 30, the agency is scientifically reviewing the updated modified risk application for General smokeless tobacco products submitted by Swedish Match’s U.S. subsidiary.

The FDA stated that the original modified risk order is valid for five years from the date of issuance. If the company wishes to continue marketing these modified risk products, it must submit an updated application to the FDA to confirm that the products still meet the requirements of Section 911. The updated application may reference the original MRTP application, as well as the Premarket Tobacco Product Applications (PMTA) and annual reports for Modified Risk Tobacco Products (MRTP) submitted in accordance with post-market order requirements.

On October 22, 2019, the FDA issued a modified risk order to Swedish Match’s U.S. subsidiary (formerly Swedish Match North America LLC) for the following smokeless tobacco products, including:

• General Loose;

• General Dry Mint Pouch Mini Original;

• General Pouch Large Original;

• General Classic Pouch White Large - 12 Pack;

• General Mint Pouch White Large;

• General Nordic Mint Pouch White Large - 12 Pack;

• General Pouch White Large;

• General Wintergreen Pouch White Large, among others.

Annual MRTP reports must include the cumulative results of all post-market surveillance and studies that companies are required to conduct to maintain modified risk status. Once all updated MRTP application materials are made public, the FDA will announce the end date of the comment period. That date will be at least 180 days after the first release of application materials and at least 30 days after the final release of application materials.