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

Kazakhstan’s Astana Baikonur District Fines Illegal Smokeless Tobacco Sales Over USD 5,800
Kazakhstan’s Astana Baikonur District Fines Illegal Smokeless Tobacco Sales Over USD 5,800
Authorities in Astana’s Baikonur District have intensified enforcement against illegal smokeless tobacco and related products in 2025. Police conducted 59 inspection raids, identifying 63 cases of illegal sales of smokeless tobacco (nasvay). Total fines imposed reached KZT 3,096,450(approximately USD 5,880). Officials said inspections and preventive outreach will continue.
Dec.29 by 2FIRSTS.ai
3,200 suspected "drug-laced cigarettes" seized in Johor Bahru, case value estimated at US$242,500
3,200 suspected "drug-laced cigarettes" seized in Johor Bahru, case value estimated at US$242,500
Malaysian police seized 3,200 suspicious e-pods with ketamine liquid, arresting two men in Johor Bahru's drug distribution bust.
Feb.04 by 2FIRSTS.ai
Philip Morris Korea launches TEREA “Shine Pearl” for IQOS ILUMA, expands capsule range to seven variants
Philip Morris Korea launches TEREA “Shine Pearl” for IQOS ILUMA, expands capsule range to seven variants
Philip Morris Korea said on Feb. 5 it has introduced “TEREA Shine Pearl,” a new TEREA stick designed for the IQOS ILUMA heated-tobacco device. The company said the product delivers a cool sensation and adds a fresh, fruity note when the capsule is crushed, bringing TEREA’s capsule-based lineup in South Korea to seven variants.
Feb.05 by 2FIRSTS.ai
Singapore HSA bust links two vape warehouses; Malaysian man jailed 41 weeks
Singapore HSA bust links two vape warehouses; Malaysian man jailed 41 weeks
HSA officers in Singapore staked out a Bishan warehouse after a tip-off and found a Malaysian man in a site containing thousands of vaporisers and components. Checks on his phone led to a second warehouse in Ubi with large quantities of devices and parts.
Jan.07 by 2FIRSTS.ai
Florida AG announces largest illegal vape seizure in state history, 2,183 contraband devices seized
Florida AG announces largest illegal vape seizure in state history, 2,183 contraband devices seized
Florida’s attorney general announced a record-breaking statewide enforcement push against illegal vaping products, with four joint operations seizing 2,183 contraband vapes and additional nitrous oxide-related items. Regulators also reported removing thousands of noncompliant products from store shelves, while investigations remain ongoing.
Feb.09 by 2FIRSTS.ai
Malaysia’s vape industry flags “policy U-turn” concerns after ban on refillable open-system e-cigarettes
Malaysia’s vape industry flags “policy U-turn” concerns after ban on refillable open-system e-cigarettes
Malaysia’s vape industry has raised concerns over the government’s decision to ban refillable open-system e-cigarettes, describing it as a policy reversal despite earlier regulatory approvals.
Jan.08 by 2FIRSTS.ai