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

On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.
BAT
Sep.01
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Former Roche Neuroscience and Rare Diseases Communications Director Ria Kioupritzi Joins PMI as Scientific Affairs Director
Eleftheria (Ria) Kioupritzi, a biopharmaceutical professional with more than 15 years of experience, has joined Philip Morris International as Director Scientific Affairs within Corporate Affairs. She previously served at Roche as Senior Scientific Communications Director for Neuroscience and Rare Diseases and worked extensively in spinal muscular atrophy. Her earlier career also covered competitive intelligence, clinical and regulatory monitoring, pipeline development and launch preparation. During her time working in Roche's SMA field, Evrysdi passed through several U.S. FDA milestones, including its initial approval, an expanded indication for younger infants and approval of a tablet formulation. Public records do not show that Kioupritzi herself led the FDA submissions.
Sep.22
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
HM Revenue & Customs put the UK's Vaping Products Duty and Vaping Duty Stamps Scheme into effect on October 1. All vaping liquids manufactured in or imported into the UK are now subject to duty at £2.20 per 10ml, regardless of nicotine content. The stamp regime will introduce digital functionality designed to provide traceability throughout the supply chain, with approved manufacturers, importers and warehousekeepers required to report product movements and retailers and consumers eventually able to scan stamps to verify authenticity. China exported $177 million of vape-related products to the UK in August, up 51.4% year over year, increasing the significance of the new compliance regime for China's Shenzhen-centered vape supply chain.
Regulations
Oct.04
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
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
Philip Morris Japan (PMJ) launched the IQOS ILUMA i PRIME Ginza Limited Model Set in Tokyo on September 4, 2026, alongside the opening of IQOS Flagship Ginza, the brand’s first global flagship store. The Oasis Blue edition is limited to 1,814 individually numbered units, with the figure derived from the store’s address at Ginza 1-8-14. The set also includes two Yamanaka-nuri glasses and special packaging, priced at JPY 11,980 and sold exclusively at the Ginza flagship.
Sep.07