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

Estonia warns of a booming illicit vape market, raising risks for minors and legitimate trade
Estonia warns of a booming illicit vape market, raising risks for minors and legitimate trade
Estonia’s Chamber of Commerce and Industry and the Tax and Customs Board are urging the government to address a thriving illicit vape market that undermines fair competition and makes vapes easily accessible to minors.
Feb.04 by 2FIRSTS.ai
Japan Tobacco Launches Limited-Edition “Purple Dusk” Colorway for Ploom AURA, Priced at JPY 2,980
Japan Tobacco Launches Limited-Edition “Purple Dusk” Colorway for Ploom AURA, Priced at JPY 2,980
Japan Tobacco has launched the fourth installment of its limited-color series for the Ploom AURA heated-tobacco device, unveiling “Purple Dusk” . Priced at JPY 2,980 (about USD 18.7, tax included), it goes on limited early sale via official channels from Jan 13, before rolling out to convenience stores and other retail outlets across Japan from Jan 20.
Jan.13 by 2FIRSTS.ai
2Firsts’ Nine Global Turning Points: How 2025 Reshaped the Nicotine Industry
2Firsts’ Nine Global Turning Points: How 2025 Reshaped the Nicotine Industry
In 2025, the global nicotine industry reached a critical turning point. Regulatory realignment, category shifts, capital repositioning and technological intervention unfolded in parallel, loosening old structures while new ones took shape. 2Firsts reviews nine pivotal events that reshaped the industry’s trajectory.
Jan.14
Haypp Reports 15% Q4 Sales Growth as Nicotine Pouch Volumes Rise
Haypp Reports 15% Q4 Sales Growth as Nicotine Pouch Volumes Rise
Haypp Group announced that net sales for October–December 2025 rose 15% year-on-year to SEK 1,052.2 million, or 19% in constant currency terms. The company recorded 28% volume growth in the nicotine pouch category during the quarter. The number of orders increased to 1.34 million, and active consumers rose to 630,000, marking the highest level in the company’s history. CEO Gavin O’Dowd said the company’s accelerating topline performance in the US and UK positions it for a strong 2026.
Market
Feb.22
FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
Feb.11
South Korean Court Strikes Down Health Levy on Vape Nicotine Liquids, Citing Disproportionate Penalties
South Korean Court Strikes Down Health Levy on Vape Nicotine Liquids, Citing Disproportionate Penalties
A Seoul court has annulled South Korea’s health-levy assessments imposed on multiple importers of nicotine liquids used for vaping. While the court agreed the nicotine could be treated as “tobacco” because it was found to be leaf-derived, it ruled the levy—stacked with other taxes and calculated on a blunt, volume-only basis—was so severe it effectively deprived businesses of the ability to operate, breaching constitutional proportionality and equality standards.
Jan.26 by 2FIRSTS.ai