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

QISI’s Dongguan Factory Posts Recruitment Notice for Production Positions

QISI’s Dongguan factory has posted new production job openings, following earlier reports of a shutdown at its Zhuhai site.

Oct.15

From Partnership to Acquisition: Why KT&G Is Betting on the Global Nicotine Pouch Market

As global competition in the nicotine pouch market accelerates, Korea’s tobacco major KT&G has moved with a “Partnership + Acquisition” strategy, teaming up with Altria to acquire Nordic pouch maker Another Snus Factory (brand “LOOP”). Why deploy capital now, and why take this route? Drawing on company disclosures, regulatory monitoring and on-site observations from InterTabac Dortmund, 2Firsts analyzes KT&G’s strategic calculus and the signals behind this move.

Nov.05

Baltimore Moves to Zone Smoke Shops, Set Minimum Distance From Schools

Baltimore’s City Council in Maryland, building on recently enacted restrictions on “small box” dollar-store chains, has proposed a package of regulations for tobacco and vape retailers. The measures would create a standalone land-use category for “smoke shops,” establish distance buffers from schools and parks, limit exterior signage brightness, and schedule an informational hearing.

Oct.29 by 2FIRSTS.ai

China Opens 2026 National E-Cigarette Standards Project for Public Submissions

The State Administration for Market Regulation (SAMR) and the State Tobacco Monopoly Administration (STMA) jointly announced the launch of the 2026 National Standardization Project for E-cigarettes. The initiative, coordinated by the National Technical Committee on Standardization of E-cigarettes, aims to enhance the industry’s regulatory framework through new standards on manufacturing, storage, distribution, and evaluation.