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

How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
How Many Nicotine Pouch Factories Does Europe Need? 2Firsts Interviews AIRSCREAM on the OEM Market
At InterTabac 2026, nicotine pouch growth was visible not only in brands but across equipment, raw materials and OEM manufacturing. 2Firsts interviewed AIRSCREAM commercial head Steve Moore on how many pouch factories Europe may ultimately need and where manufacturers can differentiate, from formulation and flavour to pouch materials, production consistency and customer service. The category continues to expand, but questions remain over future capacity, consolidation and the long-term structure of the supply chain.
Sep.18
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
A commentary published in the international open-access, peer-reviewed Harm Reduction Journal argues that randomized controlled trials remain central to evaluating smoking cessation efficacy but cannot alone capture real-world uptake, complete switching, longer-term use and population impact of non-combustible nicotine products such as e-cigarettes, heated tobacco and nicotine pouches. The authors frame impact as “reach × efficacy” and call for real-world evidence to complement RCTs. Three days after publication, the FDA authorized three JUUL2 products and highlighted complete switching among adult smokers in explaining its decision, providing a timely regulatory backdrop to the debate.
Sep.08
Altria Showcases Ploom, Marlboro Heated Tobacco Sticks and Non-Nicotine Energy Products at NACS Show 2026
Altria Showcases Ploom, Marlboro Heated Tobacco Sticks and Non-Nicotine Energy Products at NACS Show 2026
At the 2026 NACS Show, Altria displayed Ploom devices alongside imagery of Marlboro-branded heated tobacco sticks, while also featuring RIOT Energy and Proper Wild non-nicotine products. The booth showcased on! PLUS nicotine pouches, including 12 mg variants not listed among FDA-authorized products as of October 9, and NJOY e-cigarettes. Altria also presented convenience-store traffic figures highlighting its retail presence. 2Firsts examines the company's expanded product portfolio, non-nicotine business activities and the regulatory status of products displayed at the show.
EXPO
Oct.10
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
Ahead of the 2026 NACS Show, 2Firsts interviewed Chris Rapanick, NACS managing director of research, on changes reshaping the U.S. convenience-store tobacco and nicotine market. NACS data show cigarette sales declining while smokeless alternatives, including nicotine pouches, continue to grow. The interview also examines higher OTP margins, shifting backbar space, weaker store traffic, regulatory uncertainty and NACS’ outlook for 2027, offering a retailer-side view of one of the world’s largest nicotine markets.
Interview
Oct.03
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
A September online survey commissioned by Japanese smoking-accessories company Lightec found that 49.5% of respondents would consider reducing tobacco use if prices rose further, while 25.1% would consider switching to cheaper brands and 14.5% would consider using or combining alternatives such as vapes and nicotine-free herbal sticks. Another 64.6% expressed some level of interest in such alternatives. The survey covered 1,088 respondents aged 20 to 70 and was conducted by a company that sells NICOLESS nicotine-free vaping and herbal-stick products, meaning its findings should not be treated as representative of Japan's smoking population.
DATA
Oct.12
U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking
U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking
A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.
Regulations
Oct.10