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

Perak to stop issuing new vape licences, aiming for a phased “zero sales” outcome after October
Perak to stop issuing new vape licences, aiming for a phased “zero sales” outcome after October
Perak executive councillor Datuk Sivanesan said the state government aims to progressively reach a “zero” level of vape sales no later than after October, noting vape operators were clearly informed in October 2025.
Jan.05 by 2FIRSTS.ai
The UK government plans to expand the scope of its e-cigarette ban to include playgrounds, off-campus areas, and areas outside hospitals.
The UK government plans to expand the scope of its e-cigarette ban to include playgrounds, off-campus areas, and areas outside hospitals.
Government plans would ban vaping in cars carrying children and restrict smoking, vaping and heated tobacco in settings including playgrounds and outside schools across England, subject to a 12-week public consultation. The proposals also say indoor spaces where smoking is already banned would become vape- and heated-tobacco-free, and areas outside hospitals would be included.
Feb.13 by 2FIRSTS.ai
SICPA Secures Five-Year UK Vape Tax Stamp Contract
SICPA Secures Five-Year UK Vape Tax Stamp Contract
HM Revenue and Customs (HMRC) has awarded a five-year contract to Swiss technology company SICPA and Cartor Security Printers to implement the United Kingdom’s new vaping duty stamp and track-and-trace system, beginning in April 2026.
Market
Feb.24
South Korea’s Seoul Gangnam District Installs “Separated Smoking Booths” , Splitting Cigarettes and Vapes
South Korea’s Seoul Gangnam District Installs “Separated Smoking Booths” , Splitting Cigarettes and Vapes
Seoul's Gangnam district introduces smoking booths on Tehran Road to combat public smoking and secondhand smoke issues.
Jan.23 by 2FIRSTS.ai
PMI AI White Paper Warns of “Cognitive Atrophy” and Attention Erosion, Calls for Focus on Human Cognition’s Evolution
PMI AI White Paper Warns of “Cognitive Atrophy” and Attention Erosion, Calls for Focus on Human Cognition’s Evolution
Philip Morris International (PMI) has released a white paper calling for cross-sector dialogue on how AI may affect human cognitive abilities. The paper flags risks including “cognitive atrophy” and attention erosion, and warns of a widening cognitive divide and rising pressures on information verification and trust.
Jan.21 by 2FIRSTS.ai
PMI says it submitted evidence to FDA panel backing ZYN bid for modified-risk status
PMI says it submitted evidence to FDA panel backing ZYN bid for modified-risk status
Philip Morris International said it presented scientific evidence to the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee to support its ZYN nicotine pouches seeking a modified risk tobacco product designation, which would allow the company to communicate to adult smokers that switching completely to ZYN could reduce the risk of multiple smoking-related diseases.
Jan.26 by 2FIRSTS.ai