2ONE Labs Announces PMTA Submission Update, Nicotine Pouch Products Receive FDA 'Acceptance' Again

Dec.05.2024

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

References:

[1] 2ONE Labs Receives Second FDA PMTA 'Acceptance' Notification for Additionally Submitted 2ONE® Branded Nicotine Pouch Products

Also Read:

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

#North America #United States #Nicotine-free e-cigarettes #Major companies

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

China Boton Group Announces Temporary Trading Halt Pending Major Disposal Announcement

China Boton Group Company Limited (Stock Code: 3318) announced that trading in its shares on the Hong Kong Stock Exchange (HKEX) was temporarily suspended at 9 a.m. on December 8, 2025. The suspension was requested by the company pending the release of an announcement related to a “very substantial disposal.”

Dec.08 by 2FIRSTS.ai

Russia's Finance Ministry Proposes Regional Vape Sales Bans from 2026

Russian Finance Ministry has drafted amendments allowing regional governments to ban the retail sale of vapes and e-liquids between September 1, 2026, and September 1, 2031. Regions must enact their own legislation and notify the Federal Service for Alcohol and Tobacco Control (Rosalkogoltabakkontrol), which will publish a list of participating regions.

Dec.08 by 2FIRSTS.ai

Thailand to Establish Inter-Agency Committee to Strengthen E-Cigarette Enforcement

The Thai government will establish an inter-agency committee under the Prime Minister’s Office to address the rapid spread of e-cigarettes among youth. Deputy Prime Minister Sophon Sarum said the fragmented enforcement across multiple laws and agencies has created gaps. The new mechanism will coordinate enforcement, report directly to the Cabinet, and propose legal amendments if current laws are insufficient.

Nov.20 by 2FIRSTS.ai

Ireland Considering Ban on Nicotine Pouches to Protect Youth, Says Chief Medical Officer

Ireland’s Department of Health is examining a ban on nicotine pouches to curb nicotine use among young people. Chief Medical Officer Prof. Mary Horgan said the ban could be included in amendments to the current tobacco bill.