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

UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
The UK Reform Party has proposed limiting the number of dedicated vape shops in the country to around 1,000 as part of a plan to tighten oversight of vape retail channels. The proposal was put forward by Reform UK deputy leader and MP Lee Anderson. The plan remains a political proposal and has not become UK government policy, with no detailed legislation, implementation timeline or allocation rules announced.
Aug.10
 PMI Opens Generative AI Center in Portugal to Support Global Operations
PMI Opens Generative AI Center in Portugal to Support Global Operations
According to information released by Portugal’s Trade & Investment Agency (AICEP) in July 2026, Philip Morris International (PMI) has established a global Generative Artificial Intelligence Factory (GenAI Factory) at its Portuguese subsidiary Tabaqueira. The center will support PMI’s global operations by developing and deploying AI solutions focused on industrial process optimization, data analytics, operational automation and AI application development. The initiative strengthens Portugal’s role in PMI’s global technology and innovation network.
Aug.27
CCPIT Says Trade Friction Index for China-Related Electronics Sector Remains High, With Vape Products Among Areas of Focus
CCPIT Says Trade Friction Index for China-Related Electronics Sector Remains High, With Vape Products Among Areas of Focus
China Council for the Promotion of International Trade (CCPIT) held its July regular press conference on July 31, 2026, releasing the May 2026 Global Economic and Trade Friction Index. CCPIT spokesperson Yang Fan said the global trade friction index stood at 95 in May, remaining at a medium-to-high level. By industry, the electronics sector recorded the highest trade friction index among 13 monitored industries. In China-related trade frictions, the index stood at 93, with electronics products including drones, chips and vape products among areas where friction remained elevated.
Aug.03
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
China-based Shenzhen Huabao Collaborative Innovation Technology Research Institute Co., Ltd. has filed a patent application for a nicotine-ascorbic acid cocrystal, exploring a new solid-state form of nicotine. The patent proposes applications across e-liquids, heated tobacco sticks, oral tobacco, chewing tobacco and snuff. In nicotine pouch tests disclosed in the filing, cocrystal formulations showed less than a 6% decline in nicotine content after three months of accelerated storage and a release profile combining early-stage release with sustained delivery over 60 minutes. The filing reflects exploration of nicotine forms beyond conventional nicotine base and nicotine salts.
Aug.13
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
According to Interfax-Ukraine, a study conducted by market research firm Kantar Ukraine at the request of major tobacco companies found that more than 93% of vape products in Ukraine did not fully comply with regulatory requirements. The research examined product categories, brand distribution and consumer purchasing channels, showing that pod systems and disposable vapes represent major segments of the market, while offline retail remains the dominant purchasing channel. The findings highlight ongoing compliance challenges in Ukraine’s vape market.
Aug.26
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company has begun selling four flavored Vuse Pro pods — Peach, Berry, Watermelon and Fresh Mint — in Ohio and selected other U.S. markets. According to the Vuse U.S. FAQ, Vuse Pro contains approximately 5.0% nicotine by weight, and Vuse Pro pre-filled pods are intended for use with Vuse Alto devices. Reynolds told 2Firsts that product labeling lists an e-liquid capacity of 2.0 mL per pod. The Vuse Alto Power Unit received FDA marketing authorization in 2024, while the new Vuse Pro pods themselves have not received marketing granted orders. The rollout follows the FDA’s May 2026 revision of enforcement priorities for certain unauthorized vaping products with qualifying pending applications.
BAT
Sep.10