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

UK HMRC Issues One-Month Countdown Warning, Urges Vape Businesses to Prepare for New Tax Rules
UK HMRC Issues One-Month Countdown Warning, Urges Vape Businesses to Prepare for New Tax Rules
The UK’s Vaping Products Duty and Vaping Duty Stamps Scheme will take effect on October 1, 2026. All vaping liquids manufactured in or imported into the UK will face a flat excise duty of £2.20 per 10ml, whether or not they contain nicotine. Newly manufactured or imported products released onto the UK market from October 1 will require a valid duty stamp, while eligible existing unstamped inventory can continue to be sold through March 31, 2027. From April 1, 2027, all vaping products outside duty suspension must carry a valid stamp.
Sep.03
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
JTI Research Finds 31% of UK Respondents Offered Illicit Tobacco, While 63% of Ennis Packs Lack Duty Marks
Multiple JTI-backed studies in the UK and Ireland indicate that illicit tobacco remains visible across consumer interactions and local markets. In the UK, JTI research found that 31% of respondents said they had been offered illicit tobacco products. In Ireland’s Ennis area, a JTI-commissioned empty pack survey found that 63% of sampled cigarette packs did not carry Irish duty-paid markings. The findings come from industry research rather than official government estimates of illicit tobacco market size, but highlight continued concerns among regulators, legitimate retailers and tobacco companies over illicit trade.
Aug.19
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Police in Malaysia’s Selangor state seized illegal vape products and contraband cigarettes worth about RM12.7 million (approximately $3 million) in two enforcement operations. According to New Straits Times and The Star, the vape-related operation uncovered 131,036 boxes of vape products, 4,900 bottles of e-liquid and 25,510 vape devices, valued at about RM9.4 million. Police said preliminary investigations indicated that some illegal vape products entered Malaysia through sea shipments from China before moving through storage and distribution networks.
Aug.10
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
U.S. President Donald Trump has named Pastor Darrell Scott to serve as an adviser on tobacco health issues on the Centers for Disease Control and Prevention’s Advisory Committee to the Director. Trump said Scott would focus on the burden of tobacco-related disease and help examine ways to protect Americans from dangerous tobacco products while supporting solutions that reduce harm. Scott’s public career has largely centered on faith leadership, community advocacy and politics.
Sep.02
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
HM Revenue & Customs is urging members of the public to report vape shops, barber shops and other high-street businesses suspected of tax fraud, money laundering or other illegal activity, with informants not required to provide personal details. HMRC plans more than 30,000 interventions in 2026-27 targeting tax fraud, organised crime and illicit activity, including the sale of illegal vapes and tobacco. The push forms part of a broader UK effort to tackle organised crime on high streets, backed by a £30 million government enforcement programme.
Regulations
Aug.17 by 2Firsts Perspectives
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
PMI Global Communications Chief Moira Gilchrist: Why AI Matters More Than Ever in the Smoke-Free Transition
Philip Morris International (PMI) Chief Global Communications Officer Moira Gilchrist said artificial intelligence is changing how companies understand audiences, manage owned information channels and communicate business transformation. PMI is using AI-generated audience personas to test messaging while optimizing its corporate website and other owned channels for large language models. As PMI continues its transition from cigarettes toward smoke-free products, Gilchrist said owned data and corporate channels are becoming increasingly important in demonstrating the scale of that transformation.
Aug.26