
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.
We welcome news tips, article submissions, interview requests, or comments on this piece.
Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn
Notice
1. This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.
2. The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.
3. This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.
4. Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.
Copyright
This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.
For copyright-related inquiries, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.
We welcome any corrections or feedback. Please contact us at: info@2firsts.com