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
Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
DOJO officially launched the BLAST7K Fresh on September 17, 2026, introducing a UK-market prefilled pod product with 6ml of e-liquid and a manufacturer-rated capacity of up to 7,000 puffs. The device features a 1000mAh rechargeable battery, the INSTA-JUICED structure and COREX BLAST dual-mesh technology, while retaining compatibility with existing BLAST pods. The launch comes less than two weeks before the UK's Vaping Products Duty takes effect on October 1. At the new duty rate, 6ml of vaping liquid would correspond to £1.32 in VPD. DOJO has not stated that the product's 6ml format was designed in response to the new duty.
Sep.20
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
Sep.19
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s state of Victoria has activated new powers allowing Tobacco Licensing Victoria and police to shut premises suspected of selling, supplying or possessing illicit tobacco for up to 90 days. Longer closures can be ordered by a magistrates’ court. Businesses subject to closure orders must generally cease all trading and will be placed on a public list. Breaching a closure order can carry penalties of up to A$2.5 million and 20 years in prison.
Sep.10
Smoke-Free Business Hits 42% of Q2 Net Revenue as PMI’s First TNFD Report Covers Single-Use Electronics, Critical Raw Materials and IQOS Repairs
Smoke-Free Business Hits 42% of Q2 Net Revenue as PMI’s First TNFD Report Covers Single-Use Electronics, Critical Raw Materials and IQOS Repairs
Philip Morris International has published its first report aligned with the Taskforce on Nature-related Financial Disclosures, bringing its electronics supply chain and the use and end-of-life stages of smoke-free devices and consumables into its nature-related assessment. PMI said its smoke-free business accounted for about 42% of total net revenues in the second quarter of 2026. The report says non-circular electronic products, particularly single-use items, can increase consumption of limited natural resources and also details an IQOS repair pilot. A 2040 circularity scenario tests assumptions including a 50% reduction in product waste-related costs, 10% raw-material savings and a 25% substitution rate for refurbished products versus new products.
Sep.23
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup’s 2026 Consumption Habits survey tracked nicotine pouch use for the first time. The survey found that 11% of U.S. adults reported smoking cigarettes in the past week, 9% reported vaping, and 4% reported using nicotine pouches. Cigarette smoking remained near Gallup’s long-term low, while adult vaping rates stayed relatively stable in recent years.
Market
Aug.25 by 2Firsts Perspectives
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
U.S. President Donald Trump has named Pastor Darrell Scott to serve as an adviser on tobacco health issues on the Centers for Disease Control and Prevention’s Advisory Committee to the Director. Trump said Scott would focus on the burden of tobacco-related disease and help examine ways to protect Americans from dangerous tobacco products while supporting solutions that reduce harm. Scott’s public career has largely centered on faith leadership, community advocacy and politics.
Sep.02
Related Topics
HEADLINE News Company
Related Read
Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
Product | DOJO Launches 0+6ml BLAST7K Fresh in UK in September, Retaining 2+8ml Pod Compatibility Ahead of October Per-Milliliter Vaping Duty
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Smoke-Free Business Hits 42% of Q2 Net Revenue as PMI’s First TNFD Report Covers Single-Use Electronics, Critical Raw Materials and IQOS Repairs
Smoke-Free Business Hits 42% of Q2 Net Revenue as PMI’s First TNFD Report Covers Single-Use Electronics, Critical Raw Materials and IQOS Repairs
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches
2Firsts Perspectives
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
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