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

FEELM Releases Four Transparent Pod-Related Solutions for the TPD Market
FEELM Releases Four Transparent Pod-Related Solutions for the TPD Market
FEELM, a technology brand under Smoore, released four product solutions at an industry expo held in France, including OMNI POD MINI, OMNI POD MAX, TWINBREEZE, and CRYSBERG. The solutions are designed around TPD market needs and involve transparent pod design, leak-resistant structures, flavor performance, smart recognition, and different capacity configurations.
Apr.09 by 2FIRSTS.ai
Canadian Border Officers Seize Contraband Worth CAD 4.5 Million at Point Edward Crossing
Canadian Border Officers Seize Contraband Worth CAD 4.5 Million at Point Edward Crossing
The Canada Border Services Agency said border officers at the Point Edward port of entry in Sarnia, Ontario, seized more than CAD 4.5 million worth of illegal tobacco and nicotine vapes over a seven-day period. The agency said the contraband was entering Canada from the United States and described the seizure as part of ongoing efforts to prevent illegal products from entering the country and disrupt organized crime.
Mar.26 by 2FIRSTS.ai
 BAT Bangladesh Cigarette Sales Fall 14%, Q1 Profit Drops 34%
BAT Bangladesh Cigarette Sales Fall 14%, Q1 Profit Drops 34%
British American Tobacco Bangladesh reported a 14% year-on-year decline in cigarette sales volume and a 34% drop in first-quarter profit, highlighting mounting pressure from inflation, taxation, and weakening consumer spending in Bangladesh.
News
May.18
Bangladesh May Remove E-Cigarette Production and Sales Ban in Tobacco Law Amendment
Bangladesh May Remove E-Cigarette Production and Sales Ban in Tobacco Law Amendment
Bangladesh is preparing amendments to its anti-tobacco ordinance that would remove the ban on the production and sale of e-cigarettes and also delete provisions prohibiting the display of tobacco products at points of sale.
Mar.31 by 2FIRSTS.ai
Turkey’s New Tobacco Bill Draft Would Cover E-Cigarettes and Heated Tobacco Products
Turkey’s New Tobacco Bill Draft Would Cover E-Cigarettes and Heated Tobacco Products
A Turkey’s draft would impose major limits on the use of tobacco products in public buildings, educational and healthcare institutions, children’s areas, and outdoor events, while setting a 2040 target for a complete ban on the production, sale, and consumption of tobacco products. The draft also broadens the definition of tobacco products to include e-cigarettes, heated tobacco products, and all nicotine-containing systems.
Apr.13 by 2FIRSTS.ai
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Technology reported financial results on May 7, 2026, for the third quarter of fiscal 2026, covering the three months ended March 31, 2026. Revenue was $18.7 million, compared with $26.2 million in the third quarter of fiscal 2025 and $20.3 million in the prior quarter. Gross profit was $2.0 million, with gross margin of 10.7%. Net loss was $9.5 million, or $0.17 per share. The company said it held $18.0 million in cash as of March 31, 2026, up $468,000 sequentially.
May.08 by 2FIRSTS.ai