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
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
A commentary published in the international open-access, peer-reviewed Harm Reduction Journal argues that randomized controlled trials remain central to evaluating smoking cessation efficacy but cannot alone capture real-world uptake, complete switching, longer-term use and population impact of non-combustible nicotine products such as e-cigarettes, heated tobacco and nicotine pouches. The authors frame impact as “reach × efficacy” and call for real-world evidence to complement RCTs. Three days after publication, the FDA authorized three JUUL2 products and highlighted complete switching among adult smokers in explaining its decision, providing a timely regulatory backdrop to the debate.
Sep.08
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Shenzhen SKE Technology has launched the FRESA PRO in the United States, a high-capacity rechargeable disposable vape featuring Fresh Lock electromagnetic valve supply control technology. The device combines a claimed capacity of up to 40,000 puffs, dual mesh coils, dual output modes and a transparent tank design. The launch reflects the high-capacity disposable vape segment’s shift from puff-count competition toward improved e-liquid management and device-level experience.
Aug.03
Special Report｜AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
Special Report｜AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
AIR’s first half-year results as a listed company offer a new test of how far a traditional hookah business can transform. H1 2026 revenue rose 3.7%, even as Flavored Shisha Molasses shipments fell 9%, with pricing and mix supporting growth. Traditional shisha still generates almost all revenue, while OOKA, Crown Switch, Greentank and U.S. regulatory spending point to accelerating diversification. The next test is whether those investments can become a second business of meaningful scale and profitability.
Capital Markets
Aug.21
UK HMRC Unveils Red and Yellow Transitional Vape Duty Stamps Ahead of October Tax Launch
UK HMRC Unveils Red and Yellow Transitional Vape Duty Stamps Ahead of October Tax Launch
HM Revenue & Customs (HMRC) has released sample images of the UK’s transitional vaping duty stamps, showing red and yellow versions ahead of the new Vaping Products Duty and Vaping Duty Stamps Scheme starting on October 1, 2026. Transitional stamps contain physical security features but no digital scanning function. Approved businesses may purchase them through November 30 and affix them through December 31. HMRC has not stated that the red and yellow samples represent different product categories or tax statuses.
Regulations
Sep.02
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
According to Free Malaysia Today on August 26, 2026, Malaysia’s Health Minister Dzulkefly Ahmad said the Health Ministry would explain the government’s decision to withdraw its appeal against a High Court ruling involving the exemption of liquid nicotine used in vape products from the Poisons List. The High Court previously ruled that the exemption decision was irrational. Dzulkefly said withdrawing the appeal did not mean the government would stop regulating vaping, and that future regulatory approaches would continue under existing legal frameworks.
Aug.28
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
A study by CDC Foundation researchers found no sustained decline in e-cigarette sales across Alabama, Oklahoma and Louisiana, the first three U.S. states to implement e-cigarette directory laws. Louisiana initially saw a significant sales decline, followed by a rebound and a persistent reduction in product availability. Sales also shifted from nontobacco-flavored disposables toward prefilled cartridges, with Vuse Alto driving much of the increase in menthol cartridges. By April 2025, unlisted products still accounted for more than half of e-cigarette nicotine sales in all three states.
Sep.18
Related Topics
HEADLINE News Company
Related Read
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
As JUUL2 Wins FDA Authorization, Harm Reduction Journal Highlights the Role of Real-World Evidence in Nicotine Product Regulation
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Special Report｜AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
Special Report｜AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
UK HMRC Unveils Red and Yellow Transitional Vape Duty Stamps Ahead of October Tax Launch
UK HMRC Unveils Red and Yellow Transitional Vape Duty Stamps Ahead of October Tax Launch
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
Malaysia’s Vape Rules Face Review as Health Minister Dzulkefly Ahmad Addresses Dropped Nicotine Appeal
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
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 2FIRSTS. 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.
English
English
中文