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

Azerbaijan Imposes Comprehensive E-Cigarette Ban Covering Import, Export, Sales and Use, Effective April 1
Azerbaijan Imposes Comprehensive E-Cigarette Ban Covering Import, Export, Sales and Use, Effective April 1
Azerbaijan has approved amendments to its tobacco law that introduce a comprehensive ban on e-cigarettes and their components, covering import, export, production, storage, wholesale and retail sales, and use. Nicotine-containing e-cigarettes are classified as tobacco products under the revised framework. The law takes effect on April 1, 2026.
Jan.27 by 2FIRSTS.ai
 Breaking News | FDA Adds on! Plus Nicotine Pouches to PMTA-Authorized List
Breaking News | FDA Adds on! Plus Nicotine Pouches to PMTA-Authorized List
The U.S. Food and Drug Administration (FDA) has added ON! Plus nicotine pouch products to its list of authorized products, disclosing that the brand has received Marketing Granted Orders (MGO) through the Premarket Tobacco Product Application (PMTA) pathway. The update makes on! Plus the second nicotine pouch brand authorized via PMTA, following ZYN. As of publication, the FDA had not issued a separate press release on the decision.
News
Dec.20
Exclusive | China Releases E-Cigarette Regulatory “Status Report”, First Comprehensive Disclosure of Oversight Framework and International Cooperation
Exclusive | China Releases E-Cigarette Regulatory “Status Report”, First Comprehensive Disclosure of Oversight Framework and International Cooperation
As 2025 draws to a close, China’s State Tobacco Monopoly Administration has released a white paper–style “Status Report” on e-cigarette regulation, systematically outlining its oversight framework, enforcement outcomes and international cooperation. 2Firsts provides exclusive in-depth reporting and analysis, offering insight into China’s regulatory logic and governance direction.
Dec.29 by 2Firsts Perspectives
Kyrgyzstan: Jogorku Kenesh committee sends draft vape ban bills back for revisions
Kyrgyzstan: Jogorku Kenesh committee sends draft vape ban bills back for revisions
Kyrgyzstan Jogorku Kenesh committee on labor, health, women’s affairs and social issues decided to withdraw for revision two draft laws related to banning electronic nicotine delivery systems and e-cigarettes in Kyrgyzstan.
Jan.14 by 2FIRSTS.ai
Make Your Brand Understood by the People Who Matter
Make Your Brand Understood by the People Who Matter
Feb.02
Mexico City hands over 50,376 vapes and e-cigarettes for destruction, valued at USD 570,000
Mexico City hands over 50,376 vapes and e-cigarettes for destruction, valued at USD 570,000
Mexico City Head of Government Clara Brugada handed over 50,376 vapes and e-cigarettes in the Zócalo for final destruction. The report puts the value at 10 million pesos (about USD 570,000) and says the goods were seized from a stall and a warehouse in the Historic Center, with one person detained because selling these products is illegal.
Jan.19 by 2FIRSTS.ai