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

Malaysia joint operation seized $19,000 worth of vape liquid in Likas
Malaysia joint operation seized $19,000 worth of vape liquid in Likas
More than 2,300 units of vape liquid worth over RM75,000 were seized during an integrated operation at premises in Likas near Kota Kinabalu. During Ops Taring Landai E-Cigarette Mega on Feb 10 night, the Marine Police, Sabah Health Department officials and district police detected a shop displaying 92 types of vape pods and, after further searches, found 2,353 units of vape liquid stored on the premises.
Feb.11 by 2FIRSTS.ai
Product | “Mini Water-Bottle” Design, Rated at 60,000 Puffs: Al Fakher Launches New Disposable in the U.S. and UAE
Product | “Mini Water-Bottle” Design, Rated at 60,000 Puffs: Al Fakher Launches New Disposable in the U.S. and UAE
E-cigarette brand Al Fakher has recently listed its disposable hookah-style device, the Al Fakher Crown Bar 60K E-Hose X, across multiple online retail channels in the United States and the United Arab Emirates. The product features a mini water-bottle-like design, is rated for up to 60,000 puffs, comes with a 50ml e-liquid reservoir and a 1,000mAh rechargeable battery, and supports dual DTL/MTL vaping modes.
Jan.28 by 2FIRSTS.ai
Finland’s Ostrobothnia Police Seize Over 6,000 E-Cigarettes in Vaasa Raid, Probe Cross-Border Supply
Finland’s Ostrobothnia Police Seize Over 6,000 E-Cigarettes in Vaasa Raid, Probe Cross-Border Supply
According to a statement from Finland’s Ostrobothnia Police, officers seized more than 6,000 e-cigarettes during a home search in the Haapaniemi area of Vaasa in early January, after the case surfaced in connection with drug enforcement work.Police suspect the products were ordered from abroad for resale in Finland and were marketed and sold via Telegram.
Jan.29 by 2FIRSTS.ai
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
The Association of Tobacco Industry of Cambodia (ATIC) said JTI Cambodia General Manager Benjamin Cerletti has assumed the role of President following the completion of a two-year term served by his predecessor, Imperial Brands Plc.
Mar.05 by 2FIRSTS.ai
UK OPSS launches vape safety campaign focusing on use, charging and disposal
UK OPSS launches vape safety campaign focusing on use, charging and disposal
The UK Office for Product Safety and Standards (OPSS) published information on March 4, 2026, launching a new campaign to raise awareness among young people about safety issues linked to using, charging and disposing of vapes.
Mar.06 by 2FIRSTS.ai
Poland Weighs Ban on Disposable Vapes, Tightens Rules on Nicotine Pouches
Poland Weighs Ban on Disposable Vapes, Tightens Rules on Nicotine Pouches
Poland plans to amend its tobacco control legislation, proposing a ban on disposable e-cigarettes (both nicotine-containing and nicotine-free) while simultaneously tightening regulations on nicotine pouches and other novel nicotine products. Nicotine pouches may be permitted only in "tobacco flavour" variants to reduce their appeal to young people.
Mar.10 by 2FIRSTS.ai