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

Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia’s government commission on legislative activity has approved second-reading amendments to a bill on licensing trade in tobacco and nicotine-containing products that would allow Russian regions to introduce experimental bans on vape sales.
Mar.31 by 2FIRSTS.ai
West Virginia Senate Backs Vape Tax Increase to Offset Income Tax Cut
West Virginia Senate Backs Vape Tax Increase to Offset Income Tax Cut
The West Virginia Senate approved a 10% personal income tax cut on February 22, 2026, with part of the revenue offset coming from increased excise taxes on vape and e-cigarette products.
News
Feb.23
New Nicotine Products Added to Tax List in Delaware Budget Proposal
New Nicotine Products Added to Tax List in Delaware Budget Proposal
Delaware Governor Matt Meyer’s proposed FY2027 budget would significantly raise cigarette and nicotine product taxes to help close a $500 million budget gap and generate new revenue. The cigarette tax would rise from $2.10 to $3.60 per pack, with increases on moist snuff, e-liquids and other tobacco products. Supporters say the move is justified, while small businesses warn of potential sales losses.
Feb.17
Malaysian police raids across five states: 51 held and over RM1 million in vapes seized
Malaysian police raids across five states: 51 held and over RM1 million in vapes seized
Police in Malaysia detained 51 individuals and seized over RM1 million worth of electronic cigarettes and liquid refills in a five-state operation dubbed “Op E-CIG,” conducted by the GOF Central Brigade on February 10. The report said the operation involved 30 raids across Kuala Lumpur, Johor, Melaka, Selangor and Negeri Sembilan. Authorities seized 2,263 vape units and 165.463 litres of liquid.
Feb.12 by 2FIRSTS.ai
Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang City Urges Relevant Sellers to Apply for Tobacco Retailer Designation by April 23
Goyang Special City in South Korea said it has informed local sellers about the revised Tobacco Business Act, which will take effect on April 24, 2026, and urged them to apply for tobacco retailer designation.
Mar.13 by 2FIRSTS.ai
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China Caps E-Cigarette Capacity and Requires Export Compliance Proof to Curb “Involution”
China’s top tobacco regulator has issued a directive aimed at preventing excess capacity and curbing “involution-style” competition in the e-cigarette sector. The notice tightens investment controls, formalizes verified capacity management and requires exporters to submit compliance proof for destination markets, signaling a push toward higher industry concentration and stricter cross-border oversight.
Special Report
Feb.13