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

Thailand’s DDC Reaffirms Nicotine Pouches Are Regulated Under the Tobacco Products Control Act
Thailand’s DDC Reaffirms Nicotine Pouches Are Regulated Under the Tobacco Products Control Act
Thailand’s Department of Disease Control has warned the public not to believe claims that nicotine pouches are harmless, saying the products contain high levels of nicotine that can enter the bloodstream through the mouth lining and affect the nervous system and brain.
Apr.30 by 2FIRSTS.ai
Smoore International Reports 2025 Revenue of RMB 14.256 Billion, Up 20.8%
Smoore International Reports 2025 Revenue of RMB 14.256 Billion, Up 20.8%
On March 17, Smoore International Holdings Limited released its annual results for the year ended December 31, 2025. Revenue reached RMB 14.256 billion, up 20.8% year on year. Gross profit was RMB 4.857 billion, with a gross margin of 34.1%. Profit for the year was RMB 1.062 billion, down 18.5%, while adjusted profit for the year was RMB 1.530 billion, up 1.3%. By segment, revenue from enterprise customers was RMB 11.344 billion and revenue from own-brand business was RMB 2.912 billion.
Mar.18 by 2FIRSTS.ai
UK Retailers Call on Government to Better Resource Trading Standards to Fight Illicit Tobacco and Vape Trade
UK Retailers Call on Government to Better Resource Trading Standards to Fight Illicit Tobacco and Vape Trade
Retailers in the UK have called on the government to provide greater resources to Trading Standards in response to the growing trade in illicit tobacco and vapes. Fed national vice-president Hemanshu Patel made the call during a panel discussion at the National Convenience Show in Birmingham on April 15.
Apr.21 by 2FIRSTS.ai
South Africa health department agrees to exempt smokeless and non-combustible products from tobacco control bill
South Africa health department agrees to exempt smokeless and non-combustible products from tobacco control bill
At a parliamentary committee meeting in South Africa, Health Minister Aaron Motsoaledi said the health department has agreed to exempt non-combustible and smokeless products — including chewing tobacco, snus, nicotine pouches and e-cigarettes — from the Tobacco Products and Electronic Delivery Systems Control Bill. The department is prepared, at this stage, to exempt them from packaging and labelling requirements except for misleading or false claims.
Mar.06 by 2FIRSTS.ai
Philip Morris International Says Part of Owensboro ZYN Output Is Exceeding Market Demand
Philip Morris International Says Part of Owensboro ZYN Output Is Exceeding Market Demand
Philip Morris International said its Swedish Match facility in Owensboro will adjust part of its production schedule this summer in response to changing market conditions. According to a notice the company gave union leadership and employees on April 22, parts of ZYN production will shift from a 24/7 schedule back to a 24/5 schedule. The ZYN Flagship department will return to a five-day, three-shift operation.
Apr.23 by 2FIRSTS.ai
Thailand’s DDC Files Complaint Over Online Sales of Nicotine Pouches
Thailand’s DDC Files Complaint Over Online Sales of Nicotine Pouches
Thailand’s Department of Disease Control has lodged a complaint over the alleged online sale of nicotine pouches. The department said its monitoring found the products were being advertised and sold through electronic media, and a further inquiry later identified a physical shop linked to a store in Pathum Thani province.
Mar.23 by 2FIRSTS.ai