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

2Firsts Exclusive Analysis | RLX Q1 Revenue Rises 96.2%, International Business Points to a More Integrated Global Strategy
2Firsts Exclusive Analysis | RLX Q1 Revenue Rises 96.2%, International Business Points to a More Integrated Global Strategy
RLX Technology’s Q1 net revenues rose 96.2% year over year, with international business accounting for 72.3% of total revenue. Beyond the headline growth, the results point to deeper globalization: European operations, Nexus supply-chain integration and a broader product portfolio are becoming key signals to watch.
Special Report
May.20
PML Expands Its UK Smoke-Free Portfolio With LEVIA
PML Expands Its UK Smoke-Free Portfolio With LEVIA
Philip Morris Limited has launched LEVIA, a new range of zero-tobacco flavored nicotine sticks created for the IQOS ILUMA range. The product expands the company’s smoke-free portfolio in the UK and will initially be available in four variants, including Deep Mint and three capsule-based flavors. LEVIA has a recommended retail price of £5, or about $6.73, based on the European Central Bank’s April 28.
Apr.29 by 2FIRSTS.ai
Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International reported its Q1 financial results, with revenue for the period reaching RMB3.856 billion, up 41.7% year-on-year, and net profit (profit for the period) totaling RMB262.5 million, up 36.6% year-on-year. Revenue from its enterprise-focused business was RMB3.2674 billion, representing a 48.6% increase from RMB2.1989 billion in the same period last year. Revenue from its proprietary brand business was RMB588.6 million, up 12.6% from RMB522.6 million a year earlier.
Apr.10 by 2FIRSTS.ai
Indonesian drug agency chief proposes ban on e-cigarettes and e-liquid containing harmful substances
Indonesian drug agency chief proposes ban on e-cigarettes and e-liquid containing harmful substances
Indonesian drug agency chief proposes ban on e-cigarette and e-liquid in new draft law, citing dangerous substances found.
Apr.08 by 2FIRSTS.ai
Special Report | Russian Vape Compromise Faces First Hurdles
Special Report | Russian Vape Compromise Faces First Hurdles
Russia’s regional vape-ban model is facing early legal and political tests, as Perm Krai moves ahead before federal legislation is fully adopted. The case highlights uncertainty over regional authority, concerns from business groups about market fragmentation, and the risk that pressure against regional bans could revive calls for a stricter nationwide prohibition.
Industry Insight
May.28
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
RJR Vapor Loses Tax Refund Case as Texas High Court Finds VELO Pouches Taxable
The Texas Supreme Court issued a case summary on May 8, 2026, describing its decision in Hancock v. RJR Vapor Co. LLC. The dispute centered on whether RJR Vapor’s VELO oral nicotine pouches are taxable as “tobacco products” under the Texas Tax Code. Lower courts had held that the pouches were not taxable tobacco products, but the Texas Supreme Court reversed, concluding that VELO pouches are taxable because they are made of “a tobacco substitute.”
May.09 by 2FIRSTS.ai