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

Indonesian Health Ministry Says New Vape Rules Will Cover Age Limits, Advertising, and Product Standards
Indonesian Health Ministry Says New Vape Rules Will Cover Age Limits, Advertising, and Product Standards
Indonesia’s Ministry of Health is preparing to implement regulations on electronic cigarettes, as provided for in Government Regulation No. 28 of 2024. The ministry said e-cigarettes will be regulated under provisions equivalent to those applied to conventional cigarettes, including age restrictions, advertising controls, product content standards, pictorial health warnings, and bans on use in smoke-free areas.
Apr.16 by 2FIRSTS.ai
Australia’s Tasmania Tables New Bill to Strengthen Crackdown on Illicit Tobacco and Vapes
Australia’s Tasmania Tables New Bill to Strengthen Crackdown on Illicit Tobacco and Vapes
The Tasmanian government has tabled the Public Health Amendment (Prohibited Tobacco and Other Products) Bill 2026 in Parliament, proposing new offences, higher penalties and stronger enforcement powers to crack down on illicit tobacco and vaping products.
Mar.25 by 2FIRSTS.ai
Special Report|Disposable Heated Tobacco? A China Tobacco Patent Reimagines the Heated-Tobacco Stick as a Self-Contained Product
Special Report|Disposable Heated Tobacco? A China Tobacco Patent Reimagines the Heated-Tobacco Stick as a Self-Contained Product
A newly published China Tobacco patent proposes a holder-free heat-not-burn stick that integrates the filter, tobacco substrate, heating element, controller and power source into one cigarette-shaped product. It stands out not just for eliminating the external heating device, but for explicitly highlighting two less common goals in heated tobacco: restoring cigarette-like social sharing and enabling post-use recovery through a recoverable component group.
Innovation
Mar.18
Japan Says Heated Tobacco and E-Cigarette Use Is a Key Factor Behind Rising In-Flight Smoking
Japan Says Heated Tobacco and E-Cigarette Use Is a Key Factor Behind Rising In-Flight Smoking
Japan’s transport ministry said on April 14 that major Japanese airlines reported 429 passenger smoking incidents on domestic and international flights in 2025, the highest level since comparable data collection began in 2004. The government said the spread of heated tobacco products and e-cigarettes was an important factor behind the increase. Japan plans to work with airlines to raise public awareness of fire risks on aircraft.
Apr.14 by 2FIRSTS.ai
Guernsey Rejects Petition to Overturn Under-18 Vape Shop Ban
Guernsey Rejects Petition to Overturn Under-18 Vape Shop Ban
A petition seeking to overturn a new ban on under-18s entering vape shops in Guernsey has been rejected. The Health and Social Care Committee said the measure meets its objective of protecting children from exposure to vaping products.
Mar.23 by 2FIRSTS.ai
South Korea Moves Against Synthetic Nicotine Regulatory Gap as Three Companies Face Tobacco Business Act Probe
South Korea Moves Against Synthetic Nicotine Regulatory Gap as Three Companies Face Tobacco Business Act Probe
South Korea’s Ministry of Finance and Economy said on May 4 that it requested the Daejeon Metropolitan Police Agency and Gyeonggi Nambu Provincial Police Agency to investigate three sales companies on suspicion of violating the Tobacco Business Act.
May.06 by 2FIRSTS.ai