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Swedish Match U.S.A., Inc Modified Risk Tobacco Product Renewal Applications — Amendments Posting and Comment Period Closing Date

June 5, 2024

Today, FDA posted the final set of application materials related to the renewal of existing modified risk tobacco product (MRTP) orders for Swedish Match U.S.A., Inc’s General Snus products and announced a deadline for public comments. Public comments on these applications must be submitted to the docket by 11:59 pm EDT on July 5, 2024 to ensure they receive consideration by FDA. 

The application materials, redacted in accordance with applicable laws, can be found on FDA’s website. Before making a final determination on an MRTP application, FDA takes into consideration all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC). 

FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 20, 2024. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement describing the general nature of the evidence or arguments they wish to present and the names and email addresses of proposed participants, whether they would like to present online or in person, on or before June 11, 2024, by 5 p.m. EDT.

Please sign up to receive email alerts when materials from any MRTP application under scientific review have been posted or check our Swedish Match MRTP application webpage regularly for updates specific to that application. 

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