FDA Reviews Risk Modification Application for Swedish Match's Tobacco Products

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FDA Reviews Risk Modification Application for Swedish Match's Tobacco Products
The US FDA has begun a scientific review of Swedish Match's updated risk application for its general smokeless tobacco products.

According to the official website of the U.S. Food and Drug Administration (FDA), on November 30, the FDA conducted a scientific review of the risk modification application update submitted by the U.S. subsidiary of Swedish Match, a match company.


The FDA stated that the validity of the Risk Modification Order is five years from the date of issuance. If the company wishes to continue selling risk-modified products, they will need to submit an updated application to the FDA to confirm that the product still meets the requirements of the 911 provisions. The updated application can refer to the original risk modification application and include the Pre-Market Tobacco Application (PMTA) and Modified Risk Tobacco Product (MRTP) annual reports submitted based on market demand.


On October 22nd, 2019, the FDA issued a regulatory adjustment order to the US subsidiary of Swedish Match Company (formerly known as Swedish Match North America Inc) regarding the following smokeless tobacco products:


General bulk; General dry mint pocket mini original flavor; General pocket large original flavor; General classic pocket white large-12 packs; General mint pocket white large; General Nordic mint pocket white large-12 packs; General pocket white large; General holly pocket white large, etc. The annual report of MRTP needs to include the cumulative results of post-market monitoring and research conducted by all companies that have been granted risk-adjusted status. Once all updated application materials for MRTP are released, the FDA will announce the end date of the comment period, which shall be at least 180 days after the first release of the application materials, and at least 30 days after the last release of the application materials.


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