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

Haypp Report Shows Nicotine Pouches Gaining Ground as a Vape Alternative in the UK
Haypp Report Shows Nicotine Pouches Gaining Ground as a Vape Alternative in the UK
According to Haypp’s 2026 UK Nicotine Report, nicotine pouches are increasingly replacing both cigarettes and vaping. The UK market grew sharply, with Haypp and Northerner reporting a 60% year‑on‑year sales increase in 2025. Notably, 40% of users adopted pouches to quit vaping, nearly matching the 43% who used them to stop smoking. This indicates pouches are expanding beyond traditional smoking cessation and gaining traction among adults seeking non‑inhalable nicotine alternatives.
Jul.01
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
A new expert paper in JAMA urges U.S. clinicians to include nicotine e-cigarettes in smoking-cessation discussions, citing higher quit rates than nicotine replacement therapy. It also stresses that products must deliver enough nicotine to replace cigarettes, dual use should be brief, and complete switching is the goal. 2Firsts argues the recommendations matter beyond clinics: public-health professionals should reassess relative risk, regulators should preserve sufficient product appeal for adult smokers, and manufacturers should focus on helping users quit cigarettes more sustainably.
SCIENCE
Aug.03 by 2Firsts Perspectives
PMI to Launch IQOS in Argentina by End-2026 After Regulatory Shift, Targeting About 7 Million Smokers
PMI to Launch IQOS in Argentina by End-2026 After Regulatory Shift, Targeting About 7 Million Smokers
Philip Morris International (PMI) has confirmed plans to bring its IQOS heated tobacco device to Argentina by the end of 2026, after the Argentine government lifted long-standing restrictions and created a regulatory framework for heated tobacco, e-cigarettes and nicotine pouches.
News
Jun.26 by 2Firsts Perspectives
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT-owned nicotine pouch brand VELO and the McLaren Mastercard Formula 1 Team have launched a global fan engagement campaign offering motorsport enthusiasts opportunities to win exclusive team-related experiences. The initiative aims to connect racing culture, fan interaction and VELO’s brand experience across global markets. The partnership reflects BAT’s broader strategy of expanding modern nicotine product brands beyond traditional tobacco categories through lifestyle and cultural marketing.
Jul.23
UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
The UK government and devolved administrations have launched a 12-week consultation on proposals to make vapes less appealing to children, including plain white packaging, limits on device colours, restrictions on flavour names and changes to how products are displayed in shops.
Jul.10
Product | APUS Launches Chloe 50K, Bringing Purse-Inspired Design to the U.S. High-Puff Disposable Market
Product | APUS Launches Chloe 50K, Bringing Purse-Inspired Design to the U.S. High-Puff Disposable Market
APUS has introduced the Chloe 50K disposable vape, which has appeared across U.S.-facing online retail channels including Element Vape and Vapesourcing. The device combines a purse-inspired body and chain attachment with a 20ml e-liquid capacity, 1,250mAh rechargeable battery, dual mesh coil, and battery and e-liquid indicators. It is rated for up to 50,000 puffs. The product does not appear on the FDA’s current list of authorized e-cigarettes, and U.S. retail availability does not indicate FDA marketing authorization.
Jul.15