2ONE Labs Announces PMTA Submission Update, Nicotine Pouch Products Receive FDA 'Acceptance' Again

Dec.05.2024
2ONE Labs Announces PMTA Submission Update, Nicotine Pouch Products Receive FDA 'Acceptance' Again
Nicotine pouch brand 2ONE Labs Inc. has announced that it has received an 'Acceptance' notification from FDA for its second Pre-market Tobacco Application (PMTA) submission for the 2ONE® nicotine-flavored products.

LAKE TAHOE, Nev., Dec. 03, 2024-- 2ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for additional flavored 2ONE® nicotine product styles submitted to the U.S. Food and Drug Administration (FDA).

 

Welcoming receipt of this additional FDA 'Acceptance' notification, Vincent Schuman, CEO of 2ONE Labs, said: "Our strategy has always been to maintain a steady flow of supportable and responsible PMTA submissions for the 2ONE® nicotine pouch brand that reflect current adult consumer product demands. Our timely PMTA filings with the FDA reflect our company's commitment to remaining at the forefront of product innovation in the nicotine pouch marketplace."

 

"As with our previously 'Accepted' 2ONE® PMTA submission, this application will move forward to the next stage of FDA review. 2ONE Labs aims to fund these submissions to a successful 'Authorization' by FDA. Our wholesale, retail and sponsorship partners should take confidence in this additional ‘Acceptance’ as a reflection of our ability to manage and navigate the complex PMTA process, and of our commitment to supporting the 2ONE® brand in the US market."

 

Schuman added: "2ONE® Tobacco-Free nicotine pouches are for adult users (21+), who want to switch from cigarettes, cigars or traditional oral tobacco chewing products."

 

Source: GLOBE NEWSWIRE

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

FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
The U.S. Food and Drug Administration authorized 11 ZYN ULTRA nicotine pouch products made by Swedish Match USA through the premarket tobacco product application pathway on August 21, 2026. Ten of the authorized products have a labeled nicotine content of 9 mg, while ZYN ULTRA Smooth was authorized at 11 mg. The reviews were conducted through FDA’s nicotine pouch PMTA pilot program. FDA has now authorized 43 nicotine pouch products, including 23 through the pilot.
Aug.24
Imperial Brands Plans Thousands of Job Cuts Across U.S. and Europe in Cost Restructuring
Imperial Brands Plans Thousands of Job Cuts Across U.S. and Europe in Cost Restructuring
According to Reuters, citing Bloomberg News, British tobacco company Imperial Brands PLC plans to cut thousands of jobs across the United States and Europe as part of a cost reduction and organizational restructuring effort. The announcement drew market attention to the company’s shares. The move comes as global tobacco companies continue adjusting their operations amid slower cigarette market growth, changing consumer preferences and the transition toward next-generation nicotine products.
Aug.11
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
VAPORESSO introduced the PRIX MTL pod system in August 2026 in two versions, Filter and NFC. The Filter version allows users to switch between a conventional drip tip and a filter tip, while the NFC version links interchangeable panels to matching on-screen animations. PRIX features a 2,600mAh battery, a 5.5ml pod, a 0.87-inch TFT display and a maximum output of 40W, alongside Dual Mesh Impact Pods capable of operating at two resistance and power configurations. VAPORESSO's French website lists MSRP at $39.99 for the Filter version and $49.90 for the NFC version.
Market
Aug.24 by 2Firsts Perspectives
Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane 2026 Update Adds Nine Trials, Keeps High-Certainty Finding That Nicotine E-Cigarettes Improve Quit Rates Over NRT
Cochrane’s 2026 update of its living review on electronic cigarettes for smoking cessation included 80 randomized controlled trials involving 29,861 adult smokers, with nine trials added in this update. The review retained its high-certainty conclusion that nicotine e-cigarettes increase smoking cessation rates compared with nicotine replacement therapy. In absolute terms, about 10 in 100 people using nicotine e-cigarettes may quit smoking for at least six months, compared with about 6 in 100 using NRT. The review found no clear difference in serious adverse event rates between the two groups, while longer-term safety and the relative effectiveness of newer device types remain less certain.
Sep.07
From Product Innovation to Integrated Solutions: NEXTECH Expands Its Global Heated Tobacco Solutions
From Product Innovation to Integrated Solutions: NEXTECH Expands Its Global Heated Tobacco Solutions
NEXTECH launched its NEXE Pro circumferential-heating tobacco stick globally at InterTabac 2026, as the company expands from product innovation into broader heated tobacco solutions. Amid intensifying competition across global HTP markets, NEXTECH is strengthening its R&D, manufacturing and pre-launch support capabilities to serve different types of business customers.
Industry Insight
Sep.15
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 by 2Firsts Perspectives