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

Exclusive | EU Confirms End of Tobacco Policy Expert Group, Explores New Cooperation Structures as TPD Revision Continues
Exclusive | EU Confirms End of Tobacco Policy Expert Group, Explores New Cooperation Structures as TPD Revision Continues
2Firsts reporting shows that, as the European Union moves toward a future evaluation of its tobacco legislation, the Tobacco Policy Expert Group—long a key platform for coordination among Member States—formally concluded its mandate at the end of 2025. At the same time, the European Commission is exploring new cooperation structures to address the resulting institutional gap.
Jan.22
Florida HB 389 seeks statewide ban on smoking and vaping in public places and indoor workplaces
Florida HB 389 seeks statewide ban on smoking and vaping in public places and indoor workplaces
Florida lawmakers have introduced HB 389, a proposal to expand smoke-free protections by banning smoking and vaping in public places and enclosed indoor workplaces across the state. The bill broadens statutory definitions and outlines limited exceptions and compliance rules, with an effective date of July 1, 2026 if enacted.
Feb.10 by 2FIRSTS.ai
West Virginia Bill Seeks to Replace Per-mL Vape Liquid Tax With 50% Sales-Price Tax
West Virginia Bill Seeks to Replace Per-mL Vape Liquid Tax With 50% Sales-Price Tax
West Virginia proposes tax rate adjustments on e-cigarette devices and e-liquids, with penalties for late reporting. Effective from July 1, 2026.
Feb.02 by 2FIRSTS.ai
Russian Region Targets Youth Vaping and Night Alcohol Sales
Russian Region Targets Youth Vaping and Night Alcohol Sales
The Speaker of the Legislative Assembly of Russia’s Nizhny Novgorod Region said efforts to curb night-time alcohol sales and the spread of e-cigarettes will continue in 2026. While illegal alcohol trade has largely been eliminated, youth vaping remains a major concern. Regional authorities are seeking federal approval to allow local governments to impose stricter restrictions on vape sales, alongside increased health education initiatives.
Dec.22 by 2FIRSTS.ai
Germany Sees 18.2% Jump in Taxed Tobacco Substitutes in 2025, Including E-liquids
Germany Sees 18.2% Jump in Taxed Tobacco Substitutes in 2025, Including E-liquids
Germany’s Federal Statistical Office (Destatis) said 66.4 billion cigarettes were taxed in 2025, up 0.2% from 2024, while long-term volumes have more than halved since 1991 and per-capita consumption fell to 795 cigarettes. Taxed tobacco substitutes such as e-cigarette liquids reached 1.5 million liters, up 18.2% year on year.
Jan.26 by 2FIRSTS.ai
2Firsts Observation | Element Vape Launches “Made in USA” Section as Product Pages Show “Assembled in USA” and “Made in USA” Labels
2Firsts Observation | Element Vape Launches “Made in USA” Section as Product Pages Show “Assembled in USA” and “Made in USA” Labels
Element Vape, a U.S. online vaping retailer, uses origin labels such as “Made in USA” and “Assembled in USA” across disposable vape product pages and a dedicated collection page, grouping items under “Made in USA Disposable Vapes,” but the platform does not disclose on its public pages the applicable standards or evidentiary basis for these different claims.
Jan.20 by 2FIRSTS.ai