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

Australian Government launches new phase of “Give Up For Good” to help people quit smoking and vaping
Australian Government launches new phase of “Give Up For Good” to help people quit smoking and vaping
On January 19, 2026, the Australian Government launched a new phase of the “Give Up For Good” campaign, adding resources and support for Australians looking to quit smoking and vaping.
Jan.19 by 2FIRSTS.ai
Polish Government to Amend E-Cigarette Definitions, Applying  PLN 40 Excise Tax to Magnetic-attachment Devices
Polish Government to Amend E-Cigarette Definitions, Applying PLN 40 Excise Tax to Magnetic-attachment Devices
Poland plans to amend its excise tax regulations on e-cigarettes to address a loophole created by the emergence of electromagnetic iMagnetic-attachment devices in 2025. Under the proposal, products incorporating ferromagnetic components will be classified as e-cigarettes and subject to an excise tax of PLN 40 (about USD 11.2) per unit. The revised rules are expected to take effect 14 days after promulgation.
Dec.26 by 2FIRSTS.ai
Hungary’s Continental Tobacco Launches New Slay Nicotine Pouch Brand in UK Targeting Female Consumers
Hungary’s Continental Tobacco Launches New Slay Nicotine Pouch Brand in UK Targeting Female Consumers
Hungary’s Continental Tobacco Group has launched its Slay nicotine pouch brand in the UK, featuring compact, pastel-toned packaging and backed by a multi-million-pound investment and retail pilot programme to build its presence in the local market.
Dec.03 by 2FIRSTS.ai
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thai authorities arrested a 31-year-old man in Bang Bua Thong, Nonthaburi, on January 20, 2026, and seized 17,320 disposable e-cigarettes and a pickup truck. The seized goods were valued at more than THB 7 million (about USD 223,349.62).
Jan.21 by 2FIRSTS.ai
China Business Journal Reports: Multiple New E-Cigarette Policies Enter Public Consultation Phase in China, Covering Capacity Control and Credit Management
China Business Journal Reports: Multiple New E-Cigarette Policies Enter Public Consultation Phase in China, Covering Capacity Control and Credit Management
China Business Journal, citing a review of policy documents released by the State Tobacco Monopoly Administration in early 2026, said China’s latest e-cigarette rules target credit-based regulation, capacity controls and national standards revisions.Alan Zhao, co-founder of 2Firsts, said tighter oversight will speed consolidation, curb noncompliance and reduce destructive competition.
Jan.12 by 2FIRSTS.ai
Croatian decree raises excise duties on tobacco products effective January 1, 2026
Croatian decree raises excise duties on tobacco products effective January 1, 2026
Croatian government decree provides that higher excise duties on tobacco manufactures and tobacco products take effect from January 1, 2026. Excise on e-liquid is set at €0.25 per millilitre, on heated tobacco products at €211.30 per kilogram, and on a new tobacco product at €126.90 per kilogram. The decree’s explanation says 2026 budget revenue from these excises is expected to increase by €129.1 million.
Jan.07 by 2FIRSTS.ai