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

BAT’s Vuse Ultra listed as GOOD DESIGN Awards winner; features app connectivity and adjustable intensity
BAT’s Vuse Ultra listed as GOOD DESIGN Awards winner; features app connectivity and adjustable intensity
British American Tobacco’s (BAT) Vuse Ultra vaping product has been listed among winners on the U.S. GOOD DESIGN Awards website, in the “Personal Experience” category, according to the project page. The page identifies the award year as 2025 and names BAT (London) as both the entrant and the manufacturer.
Jan.20 by 2FIRSTS.ai
Malaysian Langkawi marine police seize vape devices and e-liquid worth US$43,902
Malaysian Langkawi marine police seize vape devices and e-liquid worth US$43,902
In Langkawi, Malaysia, the Marine Police seized various vape devices and e-liquid valued at RM178,400 (about US$43,902.99). Authorities believe the goods were intended to be smuggled out to a neighboring country.
Jan.15 by 2FIRSTS.ai
Malaysia High Court Sets May 15 Ruling on NGOs’ Challenge to Vape Nicotine Poisons List Exemption
Malaysia High Court Sets May 15 Ruling on NGOs’ Challenge to Vape Nicotine Poisons List Exemption
Malaysia’s High Court has fixed May 15, 2026, to deliver its decision on a judicial review application by three NGOs challenging the government’s move to exempt vape liquids and gels from the Poisons List. The applicants argue the March 31, 2023 delisting effectively deregulated vape products and created a prolonged gap until Act 852 took effect in October 2024.
Jan.30 by 2FIRSTS.ai
Product | UWELL Launches CALIBURN BAR 80K Disposable Vape, Rated for 80,000 Puffs with 6 Power Levels and 3 Airflow Settings
Product | UWELL Launches CALIBURN BAR 80K Disposable Vape, Rated for 80,000 Puffs with 6 Power Levels and 3 Airflow Settings
UWELL has launched the CALIBURN BAR 80K disposable vape on its official website. The device features a staggering 80,000-puff count and a 20 mg/ml nicotine concentration. It offers two output modes (NORMAL and BOOST) with six adjustable power levels ranging from 18W to 35W, complemented by a 3-level airflow adjustment system.
Jan.14 by 2FIRSTS.ai
Japan Tobacco seeks retail price hike for Ploom tobacco sticks; EVO and others to rise by 30 yen per pack
Japan Tobacco seeks retail price hike for Ploom tobacco sticks; EVO and others to rise by 30 yen per pack
Japan Tobacco (JT) said it has applied to raise retail prices for its heated tobacco-related products from April 1, 2026, covering 37 variants of Ploom tobacco sticks and with capsules, with most increases at 20–30 yen per pack (about $0.13–$0.19).
Jan.28 by 2FIRSTS.ai
Hampshire Trading Standards Seizes £138,000 Worth of Illegal Vapes and Tobacco in 2025
Hampshire Trading Standards Seizes £138,000 Worth of Illegal Vapes and Tobacco in 2025
According to Hampshire County Council, its Trading Standards team confiscated 116,000 illegal vape and tobacco products in 2025, worth an estimated £138,000 — a record annual haul.
Feb.02 by 2FIRSTS.ai