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

Australia’s One Nation Proposes 75% Tobacco Tax Cut, Says Lower Prices Could Hit Illicit Market
Australia’s One Nation Proposes 75% Tobacco Tax Cut, Says Lower Prices Could Hit Illicit Market
Australia’s One Nation party has proposed cutting tobacco excise by 75%, arguing that lower legal cigarette prices could narrow the gap with illicit tobacco and reduce demand for black-market products. The proposal comes as Australia continues expanding enforcement against illicit tobacco supply chains through border controls, retail inspections and organised-crime investigations. Supporters argue high taxes have contributed to illicit-market growth, while opponents warn that lower tobacco prices could undermine public-health goals. The proposal is a party policy position and has not been adopted by the Australian government.
Aug.18
Product | JNR Launches Shisha Hookah 70K E-Hookah With 60ml E-Liquid and 0.6% Nicotine
Product | JNR Launches Shisha Hookah 70K E-Hookah With 60ml E-Liquid and 0.6% Nicotine
JNR has introduced the Shisha Hookah 70K, a high-capacity rechargeable disposable vape designed around a hookah-inspired experience. The device comes prefilled with 60ml of e-liquid at 6mg/ml (0.6%) nicotine strength, alongside a 1,000mAh rechargeable battery and a 0.38Ω single mesh coil. It also features adjustable airflow and battery and e-liquid level displays. JNR claims the device can deliver up to 70,000 puffs and offers more than 20 flavors. Retail listings for the product have appeared in markets including Tunisia.
Market
Aug.24 by 2Firsts Perspectives
Vape Industry Group Loses Alabama Court Fight as State Tightens Rules on Imported Products
Vape Industry Group Loses Alabama Court Fight as State Tightens Rules on Imported Products
The Alabama Supreme Court affirmed a lower court’s refusal to issue a preliminary injunction blocking the state’s 2025 electronic nicotine delivery systems law, allowing rules requiring covered products to be U.S.-made or FDA-authorized to remain in effect.
Jul.10
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA Bans Vaping in 2026 World Cup Stadiums, Putting Nicotine Rules in Event Compliance Focus
FIFA’s 2026 World Cup stadium rules prohibit smoking, vaping and the use of any tobacco products or electronic smoking devices inside stadiums, including inner and outer perimeters, while electronic smoking devices, tobacco products, lighters and matches are listed as prohibited items, bringing nicotine-product management, venue compliance and cross-border legal differences into focus at a major global sporting event.
Jul.06
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York State will extend its tobacco products tax to “alternative nicotine products,” including tobacco-free nicotine pouches, from September 1, 2026, at a rate of 75% of the wholesale price. Distributors, wholesalers and retailers must also inventory products held as of 11:59 p.m. on August 31 and pay a floor tax. Vapor products are excluded from the new category and remain subject to New York's separate 20% supplemental sales tax on the retail price.
Aug.26
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
South Korea’s KOSDAQ-listed electronics-component maker ITM Semiconductor said its Indonesia subsidiary has begun full-scale mass production of e-cigarette devices, with first-quarter revenue from the business rising 55.4% year on year to 42.1 billion won, Maeil Business Newspaper reported.
Jul.08