Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

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

References:
[1] 2ONE Labs Receives Second FDA PMTA 'Acceptance' Notification for Additionally Submitted 2ONE® Branded Nicotine Pouch Products
Also Read:
[1] U.S. nicotine pouch brand 2ONE Labs says 2ONE® gains FDA “approval”
#North America#United States#Nicotine-free e-cigarettes#Major companies

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

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
ZYN Rolls Out “X-Low” Campaign in the UK to Target Low-Strength Nicotine Pouch Market
ZYN Rolls Out “X-Low” Campaign in the UK to Target Low-Strength Nicotine Pouch Market
Philip Morris International’s (PMI) nicotine pouch brand ZYN has launched an “X-Low” low-strength campaign in the UK, accelerating its push into the ultra-low nicotine pouch segment, with updated packaging and new flavours already rolled out in both the UK and the Philippines.
Dec.09 by 2FIRSTS.ai
GEEKBAR Announces Restock on Social Media, Pulse and Pulse X Lines Back in Stock
GEEKBAR Announces Restock on Social Media, Pulse and Pulse X Lines Back in Stock
GEEKBAR has announced a new round of restocking across multiple overseas social media platforms, bringing its flagship Pulse and Pulse X product lines back on sale, with several previously hard-to-find flavors returning simultaneously, alongside the launch of the new Thermal Edition.
Dec.17 by 2FIRSTS.ai
EU to consider Denmark's proposal for stricter tobacco tax reforms. Heating tobacco tax could increase by 132%, nicotine pouch tax by up to 1000%. 92% opposed to overall tax hike in public consultation. Concerns raised over taxing innovative smoke-free pr
EU to consider Denmark's proposal for stricter tobacco tax reforms. Heating tobacco tax could increase by 132%, nicotine pouch tax by up to 1000%. 92% opposed to overall tax hike in public consultation. Concerns raised over taxing innovative smoke-free pr
EU to debate Denmark's proposal to increase tobacco taxes, including a 132% hike for heated tobacco and 1000% for nicotine pouches.
Dec.04 by 2FIRSTS.ai
Before the Boom: Why Manufacturing Is Becoming the Deciding Factor in U.S. Nicotine Pouches — An Interview with Rena World
Before the Boom: Why Manufacturing Is Becoming the Deciding Factor in U.S. Nicotine Pouches — An Interview with Rena World
As the U.S. nicotine pouch market moves toward regulatory clarity and rapid growth, attention is shifting from demand to execution. In an interview with 2Firsts, U.S.-based manufacturer Rena explains why manufacturing capacity, quality systems, and compliance readiness are becoming decisive factors before the market fully takes off.
Jan.19
PMI Extends Ferrari Partnership to 2026, Bringing ZYN Nicotine Pouches to F1
PMI Extends Ferrari Partnership to 2026, Bringing ZYN Nicotine Pouches to F1
Philip Morris International (PMI) has announced that it will extend its partnerships with Scuderia Ferrari HP and the Ferrari Challenge through the 2026 season and beyond, with its smoke-free nicotine pouch brand ZYN set to appear on Ferrari’s F1 livery for the first time from the 2025 Abu Dhabi Grand Prix. The company estimates that, as of June 30, 2025, more than 41 million adult consumers were using its smoke-free products worldwide.
Dec.04 by 2FIRSTS.ai
Energy Marketers of America Backs White House Crackdown on Illicit Vape Shops, Urges Cleanup of ‘Gray Area’ Market
Energy Marketers of America Backs White House Crackdown on Illicit Vape Shops, Urges Cleanup of ‘Gray Area’ Market
The Energy Marketers of America (EMA) has publicly endorsed the White House’s enforcement campaign against illicit vape shops, saying it will help address the regulatory “gray area” that has emerged since 2020 due to delayed product approvals. EMA noted that a large volume of unauthorized imported disposable e-cigarettes worth about $86.5 million has been seized and called for stronger, more localized enforcement efforts to ease the burden on compliant convenience retailers.
Dec.04 by 2FIRSTS.ai
Related Topics
HEADLINE News Company
Related Read
ZYN Rolls Out “X-Low” Campaign in the UK to Target Low-Strength Nicotine Pouch Market
ZYN Rolls Out “X-Low” Campaign in the UK to Target Low-Strength Nicotine Pouch Market
2FIRSTS.ai
GEEKBAR Announces Restock on Social Media, Pulse and Pulse X Lines Back in Stock
GEEKBAR Announces Restock on Social Media, Pulse and Pulse X Lines Back in Stock
2FIRSTS.ai
EU to consider Denmark's proposal for stricter tobacco tax reforms. Heating tobacco tax could increase by 132%, nicotine pouch tax by up to 1000%. 92% opposed to overall tax hike in public consultation. Concerns raised over taxing innovative smoke-free pr
EU to consider Denmark's proposal for stricter tobacco tax reforms. Heating tobacco tax could increase by 132%, nicotine pouch tax by up to 1000%. 92% opposed to overall tax hike in public consultation. Concerns raised over taxing innovative smoke-free pr
2FIRSTS.ai
Before the Boom: Why Manufacturing Is Becoming the Deciding Factor in U.S. Nicotine Pouches — An Interview with Rena World
Before the Boom: Why Manufacturing Is Becoming the Deciding Factor in U.S. Nicotine Pouches — An Interview with Rena World
PMI Extends Ferrari Partnership to 2026, Bringing ZYN Nicotine Pouches to F1
PMI Extends Ferrari Partnership to 2026, Bringing ZYN Nicotine Pouches to F1
2FIRSTS.ai
Energy Marketers of America Backs White House Crackdown on Illicit Vape Shops, Urges Cleanup of ‘Gray Area’ Market
Energy Marketers of America Backs White House Crackdown on Illicit Vape Shops, Urges Cleanup of ‘Gray Area’ Market
2FIRSTS.ai
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 Shenzhen 2FIRSTS Technology Co.,Ltd. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland. For Chinese mainland users, please visit https://cn.2firsts.com
English
English
中文