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 Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysia Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysian police plan to use saliva test kits at roadblocks to detect drivers using synthetic liquid drugs marketed as “Piu Piu” and “Magic Mushroom,” substances that authorities say are mixed into vape liquids and inhaled through e-cigarette devices, raising road-safety concerns and adding pressure on vape regulation.
Jun.29
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s New Vape Rules Raise Bar for E-Liquid Makers and China-Linked Supply Chains, Expert Says
South Korea’s new vape regulations are reshaping the e-liquid market, raising compliance requirements for manufacturers, retailers and overseas suppliers. In an interview with 2Firsts, Korean nicotine products specialist Sam Kim discusses licensing barriers, inventory impacts, China-linked supply chains, and emerging regulatory challenges around nicotine analogues, nicotine-free products and DIY mixing. The Korean case may offer broader insights as governments worldwide adapt to rapidly evolving nicotine products.
Jul.16
BAT Estimates U.S. Unauthorized Vape Market at $9.4 Billion, Plans New Vuse and Velo Launches After FDA Enforcement Shift
BAT Estimates U.S. Unauthorized Vape Market at $9.4 Billion, Plans New Vuse and Velo Launches After FDA Enforcement Shift
British American Tobacco (BAT) CEO Tadeu Marroco said the U.S. unauthorized vape market is worth about £7 billion, or US$9.43 billion. Following a shift in FDA enforcement policy, BAT plans to launch flavored Vuse products in the third quarter and an updated Velo pouch in August or September.
Jun.15
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
UK Councils Seize More Than 1.3 Million Non-Compliant Vapes One Year After Disposable Ban
One year after the UK disposable vape ban came into force, local authorities continue to seize illegal and non-compliant vaping products. FOI data compiled by nicotine retailer Northerner shows more than 1.3 million products were seized between June 2025 and May 2026, with Bolton recording the highest number of seizures and Swansea reporting the highest estimated value.
Jul.21
French Vape Distributor Kumulus Vape Yields About 3% as Earnings Growth Stalls
French Vape Distributor Kumulus Vape Yields About 3% as Earnings Growth Stalls
Listed French vape distributor Kumulus Vape will trade ex-dividend on June 26, 2026, and pay an annual dividend of €0.10 per share on June 30, with Simply Wall St saying the payout is covered by profit and free cash flow, while weak earnings growth remains a concern.
Industry InsightMarketNews
Jun.24
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
China’s vape exports to the U.S. reached approximately $1.58 billion in the first half of 2026, remaining broadly stable from a year earlier but still below previous growth momentum. 2Firsts’ analysis of China Customs data shows that the U.S. market has not simply returned to its previous trajectory after the enforcement shock and inventory-driven swings of 2025. Instead, export momentum is shifting across product categories. Vaping devices and atomization hardware increased 15.2% year over year, while 6-methyl nicotine-related and other nicotine substitute products surged 234.7%. Meanwhile, traditional nicotine-containing vaping products continued to face pressure.
Jul.22