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

Exclusive: Altria Confirms FDA Grants Marketing Authorization to on! PLUS, Ending More Than a Year of PMTA Review
Exclusive: Altria Confirms FDA Grants Marketing Authorization to on! PLUS, Ending More Than a Year of PMTA Review
Altria on December 19 confirmed that six on! PLUS nicotine pouch products had received U.S. FDA marketing authorization, ending a PMTA review lasting more than a year after the company moved ahead with launch plans before clearance.
Regulations
Dec.20
Mexican Congress Postpones Debate on Vape and E-Cigarette Ban
Mexican Congress Postpones Debate on Vape and E-Cigarette Ban
Mexico’s Chamber of Deputies has postponed the debate on a reform to the General Health Law that seeks to completely ban the sale and distribution of electronic cigarettes and vapes. Lawmaker Amancay González Franco (MC) criticized the draft for excluding tobacco heating devices, such as Philip Morris’s IQOS, arguing that these products are even more harmful according to the World Health Organization.
Dec.05 by 2FIRSTS.ai
Special Report | Belarus to centralize vaping market under state supervision
Special Report | Belarus to centralize vaping market under state supervision
Belarus is preparing to overhaul its vaping market under tight state control — from monopolizing imports to banning online sales and restricting retail licenses. Officials say nearly 77% of the disposable e-cigarette market is supplied illegally, prompting sweeping regulatory measures that have already sparked strong pushback from consumers and vape retailers.
Dec.03
BAT Taps McLaren Title Win for Travel Retail Activation, Launches VELO “Champions’ Edition” Nicotine Pouches
BAT Taps McLaren Title Win for Travel Retail Activation, Launches VELO “Champions’ Edition” Nicotine Pouches
British American Tobacco (BAT) is leveraging McLaren F1 Team’s 2025 Constructors’ Championship win to roll out a VELO×McLaren brand activation across the travel retail market. The campaign spans major airports in Abu Dhabi, the UK, Ireland and Spain, alongside the launch of a VELO “Champions’ Edition” product.
Dec.15 by 2FIRSTS.ai
Croatian decree raises excise duties on tobacco products effective January 1, 2026
Croatian decree raises excise duties on tobacco products effective January 1, 2026
Croatian government decree provides that higher excise duties on tobacco manufactures and tobacco products take effect from January 1, 2026. Excise on e-liquid is set at €0.25 per millilitre, on heated tobacco products at €211.30 per kilogram, and on a new tobacco product at €126.90 per kilogram. The decree’s explanation says 2026 budget revenue from these excises is expected to increase by €129.1 million.
Jan.07 by 2FIRSTS.ai
Uruguay Weighs Ban on Nicotine Pouches as Health Ministry Warns of Growing Use
Uruguay Weighs Ban on Nicotine Pouches as Health Ministry Warns of Growing Use
Nicotine pouches, promoted as flavored, smoke-free alternatives, are spreading in Uruguay despite the absence of a formal market. The Ministry of Public Health is considering banning them by decree and has raised the issue within Mercosur and at COP11. Health Minister Cristina Lustemberg warns that the industry is pushing new nicotine products to normalize consumption among youth.
Nov.20 by 2FIRSTS.ai