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

PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
Philip Morris International's PMI Business Solutions Philippines has expanded its global business services hub in Makati and plans to add more than 80 positions. Established in 2021 primarily to provide finance and IT support to about 20 markets, the center now employs 519 professionals delivering roughly 600 services across 160 markets. Its functions now span finance, human resources, IT, commercial operations, data analytics, supply chain and project management. PMI says the hub's next phase will focus on AI-enabled and higher-value work. The company did not disclose the size or investment cost of the expansion.
Sep.24
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
IQOS opened its first global flagship, IQOS Flagship Ginza, in Tokyo on September 4, 2026, replacing the former IQOS Store Ginza after nearly a decade of operation. The new location expands conventional product retail into member lounges, digital experiences, art installations and brand programming. IQOS also launched a Ginza-exclusive IQOS ILUMA i PRIME set limited to 1,814 individually numbered units, priced at JPY11,980, or about US$77. PMI Sales Strategy Consultant Yuji M. later said on LinkedIn that more than 500 people had lined up from the night before the opening.
Sep.07
Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price
Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price
Japan Tobacco (JT) will expand EVO Cacao Mint Crystal from limited channels to nationwide retail in Japan from October 6, 2026. The Ploom tobacco stick ranked first in the brand's first consumer voting campaign for new tobacco-stick SKUs held earlier this year. JT will also introduce a limited 22-stick pack at the same JPY 620 price as the standard 20-stick pack. The capsule-format product combines menthol with sweet, bittersweet cacao notes and adds a berry nuance when the capsule is crushed.
Sep.09
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona's First Things First is pushing for an excise tax equal to 50% of the retail price of vaping products, estimating that the measure could generate about $100 million annually. The agency says its tobacco-tax revenue has fallen 47% from 2008 levels. Arizona has attempted to broaden its nicotine tax base in each of the past two years: a 2025 bill proposed a 50% wholesale-price tax, while a 2026 measure shifted to a 50% retail-price tax covering alternative nicotine products and vapor products. Separately, the state enacted HB 4001 this year to establish a new licensing and sales framework for alternative nicotine products.
Sep.21
China STMA Deputy Administrator Meets KT&G COO as Heated Cigarette Rules Advance
China STMA Deputy Administrator Meets KT&G COO as Heated Cigarette Rules Advance
Wang Gongcheng, deputy administrator of China’s State Tobacco Monopoly Administration, met KT&G Chief Operating Officer Lee Sang-hak in Shanghai on September 1, according to Oriental Tobacco News. The meeting comes as China seeks public comment on a draft mandatory national standard for heated cigarettes. The report did not disclose the subjects discussed or indicate whether heated tobacco products or market access were addressed.
News
Sep.02
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
Less than a week after JUUL2 received U.S. FDA marketing authorization on August 28, 2026, JUUL Labs was sued for patent infringement in federal court in Delaware. AJ Marketing LLC filed the complaint on September 3, alleging that both JUUL 1 and JUUL2 infringe U.S. Patent No. 8,851,068 B2. The patent covers aspects of programmable electronic vaporization devices, including controls over dose delivery, usage frequency and operating parameters. The plaintiff is seeking reasonable royalties and ongoing royalties tied to the remaining life of the patent. JUUL has not yet publicly responded to the case.
Sep.10