U.S. nicotine pouch brand 2ONE Labs says 2ONE® gains FDA “approval”

Oct.30.2024

U.S. nicotine pouch brand 2ONE Labs announces its product 2ONE® has received Premarket Tobacco Product Application (PMTA) “approval” from the FDA, marking its progression to the next stage in the FDA review process.

2ONE Labs announced on October 29 that its 2ONE® brand of nicotine pouches has received approval from FDA for its Pre-Market Tobacco Product Application (PMTA), according to Globe Newswire.

Translation into English: Nicotine pouch brand "2ONE" from 2ONE Labs | Image source: 2ONE Labs official website

After receiving the “approval” notification from the FDA, 2ONE Labs CEO Vincent Schuman stated:

“This signifies that the PMTA application for 2ONE® has advanced to the next critical phase of the FDA review process. Our company will continue to provide financial backing to ensure the successful completion of this submission. Our wholesale, retail, and sponsorship partners should view this ‘approval’ as a testament to our ability to navigate the complex PMTA process and our firm commitment to supporting the long-term availability of the 2ONE® brand in the U.S. market.”

“The 2ONE® nicotine pouches were developed for adult users (21+) who face challenges transitioning from combustible tobacco or traditional oral tobacco products to alternative options. Over the past five years, the 2ONE® brand has garnered market attention and growth, thanks to strong distribution partnerships like those with CircleK®. FDA’s approval of 2ONE®’s PMTA application is exciting, and we look forward to continuing to support adult consumers seeking alternatives to traditional tobacco products.”

References:

[1] 2ONE Labs, 미 식품의약국 (FDA)담배 제품 센터로부터 2ONE® 니코틴 파우치 브랜드에 대한 PMTA '승인' 획득

Also Read:

[1] Lawsuit Filed Against Imperial Brands Over Trademark Infringement

[2] NFL player Baker Mayfield caught using nicotine pouches on the field

[3] The Rise of Nicotine Pouches Among Young Adults

[4] San Francisco Prosecutor David Chiu Sues Four Online Tobacco Retailers

#North America #United States #Market #Nicotine-free e-cigarettes

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

Thailand National Health Commission Advances Vape Regulation Aligned with Anti-Drug Agenda

Thailand’s Deputy Prime Minister Sophon Saram, who chairs the National Health Commission (NHC), presided over a meeting aligning the nation’s e-cigarette control policies with the government’s “Quick Big Win” anti-drug strategy. The session reviewed progress under the National Health Assembly Resolution on Protecting Children and Youth from E-Cigarettes, which includes five key measures on awareness, enforcement, and prevention.

Nov.05 by 2FIRSTS.ai

Mongolia Proposes Full Regulation of E-Cigarettes Under Tobacco Law

Mongolia’s Parliament has begun reviewing major amendments to the Tobacco Control Law, which would bring e-cigarettes and other new nicotine products under the same legal framework as traditional cigarettes. The bill also proposes a gradual increase in tobacco excise taxes through 2030 and new restrictions on flavors, marketing, and public smoking.

Nov.26 by 2FIRSTS.ai

Smoore’s Q3 Revenue Hits Record High, Reflecting Structural Growth in Global HNB and E-Vapor Markets

Smoore posted record-high Q3 2025 revenue, driven by growth in both HNB and e-vapor segments, reflecting ongoing expansion of the global next-generation tobacco industry amid compliance and structural upgrades.

Oct.12

Tasmania, Australia Will Introduce New Laws Targeting Illegal Vape and Tobacco Retailers

Tasmania will introduce new laws next year to tackle the illegal trade in tobacco and vapes. The legislation will strengthen penalties, allow inspectors to issue on-the-spot fines and shut down non-compliant retailers, and enhance coordination between police and health authorities.