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

Thai Customs Plans Shift to Per-Unit Fines for Vapes at THB 100 Per Item
Thai Customs Plans Shift to Per-Unit Fines for Vapes at THB 100 Per Item
Thai Customs said on March 18 that it had seized more than 27.3 million foreign cigarettes and 205,445 vape products and related devices in mid-February, with a total value of more than THB 169 million.
Mar.19 by 2FIRSTS.ai
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
Cambodia’s tobacco industry association ATIC appoints JTI Cambodia GM as president
The Association of Tobacco Industry of Cambodia (ATIC) said JTI Cambodia General Manager Benjamin Cerletti has assumed the role of President following the completion of a two-year term served by his predecessor, Imperial Brands Plc.
Mar.05 by 2FIRSTS.ai
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris said that after investing USD 5.00 million last year to promote its ZYN nicotine pouch brand in Ukraine, it plans to invest another USD 10.00 million this year to develop the nicotine pouch category and launch a new ZYN line.
Apr.08 by 2FIRSTS.ai
Special Report | China’s New Five-Year Plan Highlights “Health-First” Strategy, Providing Policy Context for Tobacco Sector
Special Report | China’s New Five-Year Plan Highlights “Health-First” Strategy, Providing Policy Context for Tobacco Sector
China’s 2026 “Two Sessions” reviewed the draft Outline of the 15th Five-Year Plan, which proposes implementing a health-first development strategy and strengthening the effectiveness of the Patriotic Health Campaign. Although the document does not address specific industries, this public-health governance framework provides a new policy context for observing the future regulation, product strategies, and market development of China’s tobacco and next-generation nicotine sectors.
Industry Insight
Mar.08
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Netherlands Plans Law to Ban Possession of Large Quantities of Vapes Intended for Trade
Dutch Health Minister Hermans is drafting legislation that would also ban possession of larger quantities of vapes, allowing the Netherlands Food and Consumer Product Safety Authority to intervene earlier and seize stock before proving that trade has taken place.
Apr.13 by 2FIRSTS.ai
UKVIA Says VApril 2026 Will Highlight Consumer Impact of Tobacco and Vapes Bill
UKVIA Says VApril 2026 Will Highlight Consumer Impact of Tobacco and Vapes Bill
The UK Vaping Industry Association said it will launch the ninth annual VApril campaign next month. The association described VApril as the world’s largest vape awareness initiative and said it has for almost a decade supported adult smokers looking to quit through vaping by providing evidence-based information, expert insights and practical guidance
Mar.24 by 2FIRSTS.ai