FDA Updates Modified Risk Tobacco Product Orders for Swedish Match USA

Regulations by 2FIRSTS.ai
Jul.04.2024
FDA Updates Modified Risk Tobacco Product Orders for Swedish Match USA
FDA reissues two applications related to Swedish Match's General Snus products, extending public comment period for further review.

According to a news update on the official website of the US Food and Drug Administration (FDA) on July 3, FDA has reissued two application documents related to the Modified Risk Tobacco Product (MRTP) order for Swedish Match USA, Inc.'s General Snus products. These reissued documents contain previously edited content and are now available for viewing on the Swedish Match MRTP application webpage.

 

In addition, the FDA has extended the public comment period for the Swedish Match Company's MRTP update application to allow the public more time to review the recently reissued application materials. The public can submit comments on the application on the regulations.gov webpage with the docket number FDA-2014-N-1051. The FDA will announce the deadline for the comment period after it is determined.

 

These application materials have been edited in accordance with applicable laws and regulations and can be found on the FDA's website. Before making a final decision on the MRTP application, the FDA will consider all available information, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC).

 

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

U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026 will bring together international experts to discuss European regulation, tax policy, Track & Trace, market access, retail impacts, consumer behavior and innovation. Sessions will also examine Poland’s tobacco-growing perspective and the growing fragmentation of Europe’s tobacco and nicotine market. Media partner 2FIRSTS will host the second “2FIRSTS Connect at InterTabac” on September 16, focusing on developments in China’s tobacco and nicotine industry.
Aug.06
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
Product | JTI Philippines Expands Nordic Spirit Nicotine Pouch Portfolio With Dark Pop and Red Frost
Product | JTI Philippines Expands Nordic Spirit Nicotine Pouch Portfolio With Dark Pop and Red Frost
JTI Philippines has expanded the Nordic Spirit nicotine pouch portfolio in the Philippines with two new variants, Dark Pop and Red Frost. Both products maintain the brand’s tobacco-free nicotine pouch positioning, with Dark Pop featuring a fizzy cola profile with citrus and sweet notes, while Red Frost combines cool mint with sweet red berry flavors. The two variants are now available through Philippine online retail channels.
Aug.18
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
2Firsts Data | China’s Vape-Related Exports Rise 16.5% in July 2026 as U.S.-Bound Shipments Jump 53.5%
China’s vape-related exports reached $1.047 billion in July 2026, up 16.5% year on year and the highest monthly total of the year. Growth was heavily concentrated in the U.S., where exports jumped 53.5% to $404 million and accounted for 94.9% of the overall increase. Exports to all other markets rose just 1.2%. By category, nicotine-containing non-combustible products—primarily vapes—under HS24041200 rose 24.7% and generated 95.5% of the total increase. Vape-device exports under HS85434000 fell 0.4%, while other nicotine-substitute products under HS24041990 grew 88.9% but remained comparatively small.
DATA
Aug.24