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

Tobacco Companies Are Redesigning Nicotine Products. BAT Wins Three Red Dot Awards
Tobacco Companies Are Redesigning Nicotine Products. BAT Wins Three Red Dot Awards
According to BAT and the Red Dot Design Award website, BAT’s glo Hilo Plus, Vuse Pro One Box and Vuse Ultra x McLaren F1 Team Limited Edition received Red Dot recognition in the Product Design 2026 competition.BAT said the awards reflect not only the design quality of the individual products but also the development of design as a core internal capability across industrial design, user experience and sustainability. Red Dot’s product pages describe glo Hilo Plus as a two-part tobacco heater with a pen and charging case, plus a touch-sensitive AMOLED display. Vuse Pro One Box is described as a rechargeable e-cigarette with replaceable pods, USB-C charging and a switchable VapourBoost mode. Vuse Ultra x McLaren F1 Team Limited Edition brings motorsport-inspired design elements into a compact e-cigarette device and includes exchangeable batteries.
Jul.17
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026: Further Sessions on Regulation, Market Access and Innovation Confirmed; 2FIRSTS to Host China Market Forum
InterTabac 2026 will bring together international experts to discuss European regulation, tax policy, Track & Trace, market access, retail impacts, consumer behavior and innovation. Sessions will also examine Poland’s tobacco-growing perspective and the growing fragmentation of Europe’s tobacco and nicotine market. Media partner 2FIRSTS will host the second “2FIRSTS Connect at InterTabac” on September 16, focusing on developments in China’s tobacco and nicotine industry.
Aug.06
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa Enforces Vape Registry Law as Retailers Warn Product Limits Could Increase Store Pressure
Iowa has begun enforcing its vape registry law, requiring vape products to be registered before they can be legally sold in the state. The move follows a decision by the U.S. Court of Appeals for the Eighth Circuit to lift an injunction that had blocked enforcement. Retailers have warned that tighter product availability rules could increase pressure on vape shops. One Iowa retailer said that if only a limited number of products remain available, many stores could face significant business challenges.
Aug.06
BAT New Categories Revenue Rises 18% in H1 2026 as Broad Portfolio Offers More Ways to Win—and Lose
BAT New Categories Revenue Rises 18% in H1 2026 as Broad Portfolio Offers More Ways to Win—and Lose
British American Tobacco’s New Category revenue rose 18% at constant rates in the first half of 2026. Nicotine-pouch brand Velo expanded rapidly, while Vuse recovered as U.S. enforcement against illicit e-vapor products strengthened. Heated-tobacco platform glo remained under pressure, and cigarettes continued to provide most of the group’s profit and cash. Compared with PMI and JT, BAT has more routes to growth—but also greater regulatory, investment and execution risks across its broader portfolio.
BAT
Jul.30
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
Shanghai Tobacco Group Co., Ltd., a tobacco manufacturing company under China National Tobacco Corporation (CNTC), has launched a public tender for heated tobacco products (HTPs) production utility equipment at its Shanghai Cigarette Factory. The project is valued at CNY 10.98 million and covers six combined air-conditioning units, electrical cabinets and control systems for production facilities. The procurement includes equipment design, supply, installation, commissioning and related training services.
Aug.07